Methods and devices for treating hypertension

ABSTRACT

Devices, systems and methods are described which control blood pressure and nervous system activity by stimulating baroreceptors. By selectively and controllably activating baroreceptors and/or nerves, the present invention reduces blood pressure and alters the sympathetic nervous system; thereby minimizing deleterious effects on the heart, vasculature and other organs and tissues. A baroreceptor activation device or other sensory activation device is positioned near a dermal bone to provide the treatment.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND

This invention relates generally to methods and devices for thetreatment of hypertension. More specifically, methods and devices whichtreat hypertension using devices disposed extra corporally.

Hypertension, or high blood pressure, affects millions of people everyday and is a serious health hazard. Hypertension is associated with anelevated risk for heart attack, heart failure, arterial aneurysms,kidney failure and stroke. There are many factors that may affect bloodpressure, such as: salt intake, obesity, occupation, alcohol intake,smoking, pregnancy, stimulant intake, sleep apnea, geneticsusceptibility, decreased kidney perfusion, arterial hardening andmedication(s). Many times people are unaware that they suffer fromhypertension until it is discovered during a medical check-up with theirhealth care practitioner (HCP), or worse, it is discovered when they arehospitalized for a hypertension related condition such as a heart attackor stroke.

Blood pressure is controlled by a complex system within the body, onecomponent of this system is known as the arterial baroreflex (ABR). Thebaroreflex is the fastest autonomic reflex responding to changes inblood pressure. The baroreceptor nerve endings are embedded in vesselsthroughout the circulatory system and encode both mean pressure and rateof change of pressure as a frequency. Centers in the brainstem processspikes in the frequency information, integrating it with otherinformation and providing a signal to the sinoatrial (SA) pacemakingnode of the heart via efferent fibers in the vagus nerve. When bloodpressure becomes too high, the resulting vagal nerve signal triggers therelease of acetylecholine at the SA node of the heart, slowing the heartrate and thus lowering the blood pressure.

Baroreceptors are located in the transverse aortic arch and the carotidsinuses of the left and right internal carotid arteries. Thebaroreceptors found within the aortic arch monitor the pressure of blooddelivered to the systemic circuit, and the baroreceptors within thecarotid arteries monitor the pressure of the blood being delivered tothe brain.

As described above, the arterial baroreceptors are stretch receptorsthat are stimulated by distortion of the arterial wall when pressurechanges. The baroreceptors can identify the changes in the average bloodpressure or the rate of change in pressure with each arterial pulse.Action potentials triggered in the baroreceptor endings are thenconducted to the brainstem where central terminations (synapses)transmit this information to neurons within the solitary nucleus. Reflexresponses from such baroreceptor activity can trigger increases ordecreases in the heart rate. Arterial baroreceptor (ABR) sensory endingsare simple, sprayed nerve endings that lie in the tunica adventitia ofthe artery. An increase in the mean arterial pressure increasesdepolarization of these sensory endings, which results in actionpotentials. These action potentials are conducted to the solitarynucleus in the central nervous system by axons and have a reflex effecton the cardiovascular system through autonomic neurons.

At normal resting blood pressures, baroreceptors discharge atapproximately 1 out of every 3 heart beats. If blood pressure falls, thearteries retract in diameter and the baroreceptor firing rate decreaseswith the drop in blood pressure the brain send a signal to the heart toincrease blood pressure by increasing heart rate. Signals from thecarotid baroreceptors are sent via the glossopharyngeal nerve (cranialnerve IX). Signals from the aortic baroreceptors travel through thevagus nerve (cranial nerve X). Arterial baroreceptors inform reflexesabout arterial blood pressure.

The arterial baroreflex system is a dynamic system that is capable ofadapting to ever changing situations. The ABR is the reason why we donot pass out when moving from a seated to standing position. In thisinstance the ABR senses a change in blood pressure and accommodates thechange by sending the appropriate signal to regulate blood pressure. TheABR system also performs an essential function to regulate bloodpressure during exercise, wherein during exercise your heart rateincreases as well as your blood pressure, however, at a certain pointduring exercise the ABR will intervene, allowing the heart rate tofurther increase but not allowing the blood pressure to furtherincrease.

As stated above, hypertension currently affects a large and growingpopulation. Currently treatments for hypertension range from prescribedlifestyle changes and the use of pharmaceutical products. Within thepast couple of years, new surgical therapies are emerging. Thesesurgical therapies either lead to the implantation of a device forstimulating a patient's carotid baroreceptor or to the disconnection ofthe nerves of the renal arteries.

If prescribed lifestyle changes do not address a patient's hypertension,their HCP will typically prescribe drug therapy to treat theirhypertension. There are multiple classes of pharmaceutical products thatcan be utilized to treat hypertension. These include vasodilators toreduce the blood pressure and ease the workload of the heart, diureticsto reduce fluid overload, inhibitors and blocking agents of the body'sneurohormonal responses, and other medicaments. Many times, a HCP willprescribe one or more of these products to a patient to be taken incombination in order to lower their blood pressure. However, the use ofpharmaceutical products is not without their risks. Many of theseproducts carry severe warnings of potential side effects. Additionally,each patient may respond differently to the products, therefore multipleoffice visits may be required before the right dosage and type ofpharmaceutical products are selected, which leads to greater health carecosts. Further still there are a number of patients who either do notrespond to medication, refuse to take medication, or over time themedication no longer provides a therapeutic effect. Recently, newclinical trial data has drawn correlations between the use of diureticpharmaceutical products to treat high blood pressure and the formationof diabetes within the patient.

For patients who do not respond to drug therapy, there are medicaldevices and treatments that can be utilized to treat high bloodpressure. Some of these devices involve invasive surgical proceduresincluding the implantation of a permanent medical device within apatient's artery to impart a force at a specific location within theartery which then may cause a lowering of blood pressure. However, thesedevices are relatively new or are still under development and have notbeen proven over a long period of time. Also, since the device is apermanent implant, there is always the possibility of complicationsduring the implantation process or infections related to theimplantation.

As described above, another type of invasive medical device is anelectrical signal generating implant, where electrodes are placedadjacent to the carotid artery. With this process, the surgeon must becareful not to sever any of the nerves while implanting the device. Ifthe nerves are severed, then the device will not function properly andmay lead to long term health complications for the patient. However,even more troubling is that the patient has now permanently lost abaroreceptor for controlling blood pressure naturally, which may lead tocomplications later, which are currently unknown. Additionally, theimplant device requires regular battery replacement, which to do sorequires another invasive surgical procedure.

Another type of invasive medical device and procedure being developed isthe use of ablation catheter to denervate the carotid body, specificallythe chemoreceptors of the carotid body. Similar to the device andprocedure described above, this device permanently causes adisconnection between the chemoreceptors and the nervous system/brain.The long term effects are unknown, additionally, other nerves maybedestroyed or disconnected during the procedure which may lead to otherside effects.

Another type of invasive medical procedure to treat hypertension beingdeveloped is to use an ablation catheter placed within the renal artery,where a series of energy pulses are performed to ablate (sever) thenerves surrounding the artery, thereby effectively disconnecting thenerves of the kidney from the body. This procedure results in apermanent and non-reversible change to the patient's nervous system,this procedure is being referred to as renal nerve ablation or renaldenervation. The long term effects of such a permanent treatment areunknown at this time as this approach is relatively new on the market.Recently published data has shown that not all patients respond to thissurgical procedure, that is after the procedure, some of the patientsshow little to no changes in their blood pressure. This may beconcerning as now these patients have had their renal arteriespermanently disconnected from their kidneys, which may lead to long termeffects which are unknown at this time. Additionally, the costsassociated with an invasive medical procedure are not insignificant,only to prove that the procedure had no effect, thus, instead ofpotentially lowering the cost of treatment for these patients, the costof treating their hypertension was significantly added to.

Additionally, the recently published data also shows that patients whorespond to renal denervation may still remain hypertensive. Thus, therenal denervation procedure may not be a “cure,” instead it may be seenas an adjunctive therapy, as such these patients may remain on drugtherapies or are recommended to remain on drug therapy after havingundergone renal denervation.

Yet another invasive surgical approach to address hypertension is acombination of a device and a pharmaceutical product, wherein a catheterwith a needle disposed near its distal end are placed within the renalartery. Once in position, a liquid pharmaceutical product is injectedinto the wall of the artery, whereby the pharmaceutical product isdesigned to chemically ablate the renal nerves. Here again, thistreatment procedure is considered to be a permanent solution, wherebythe nerves are permanently severed. Long term efficacy of the severingof the renal nerves is unknown. Additionally, long term effects of theprocedure are also unknown.

Human skin acts as the protective barrier between our internal bodysystems and the outside world. Our skin in combination with our bodiesnerves provides for the ability to perceive touch sensations and givesour brains a wealth of information about the environment around us, suchas temperature, pain, and pressure. Without such a nervous system, wewouldn't be able to feel our feet hitting the floor when we walked, wewouldn't sense when something sharp cut us, and we wouldn't feel thewarmth of the sun on our skin.

Human skin is composed of several layers. The very top layer is theepidermis and is the layer of skin you can see. In Latin, the prefix“epi-” means “upon” or “over,” thus the epidermis is the layer uponwhich the dermis is disposed (the dermis is the second layer of skin).The epidermis, made of dead skin cells, is waterproof and serves as aprotective wrap for the underlying skin layers and the rest of the body.It contains melanin, which protects against the sun's harmful rays andalso gives skin its color. When you are in the sun, the melanin buildsup to increase its protective properties, which also causes the skin todarken. The epidermis also contains very sensitive cells called touchreceptors that give the brain a variety of information about theenvironment the body is in.

The second layer of skin is the dermis. The dermis contains hairfollicles, sweat glands, sebaceous (oil) glands, blood vessels, nerveendings, and a variety of touch receptors. The dermis' primary functionis to sustain and support the epidermis by diffusing nutrients to it andreplacing the skin cells that are shed off the upper layer of theepidermis. New cells are formed at the junction between the dermis andepidermis, and they slowly push their way towards the surface of theskin so that they can replace the dead skin cells that are shed. Oil andsweat glands eliminate waste produced at the dermis level of the skin byopening their pores at the surface of the epidermis and releasing thewaste.

The bottom skin layer is the subcutaneous tissue which is composed offat and connective tissue. The layer of fat acts as an insulator andhelps regulate body temperature. It also acts as a cushion to protectunderlying tissue from damage when you bump into things. The connectivetissue keeps the skin attached to the muscles and tendons underneath.

Our sense of touch is controlled by a huge network of nerve endings andtouch receptors disposed within the skin which is known as thesomatosensory system. This system is responsible for all the sensationswe feel: cold, hot, smooth, rough, pressure, tickle, itch, pain,vibrations, and more. Within the somatosensory system, there are fourmain types of receptors; mechanoreceptors, thermoreceptors, nociceptors,and proprioceptors.

It is important to understand how specialized receptors adapt to achange in stimulus (anything that touches the skin and causes sensationssuch as hot, cold, pressure, tickle, etc.). A touch receptor isconsidered rapidly adapting if it responds to a change in stimulus veryquickly. This means that it can sense right away when the skin istouching an object and when it stops touching that object. However,rapidly adapting receptors can't sense the continuation and duration ofa stimulus touching the skin (how long the skin is touching an object).These receptors best sense vibrations occurring on or within the skin. Atouch receptor is considered slowly adapting if it does not respond to achange in stimulus very quickly. These receptors are very good atsensing the continuous pressure of an object touching or indenting theskin but are not very good at sensing when the stimulus started orended.

Mechanoreceptors are receptors which perceive sensations such aspressure, vibrations, and texture. There are four known types ofmechanoreceptors whose only function is to perceive indentions andvibrations of the skin: Merkel's disks, Meissner's corpuscles, Ruffini'scorpuscles, and Pacinian corpuscles.

The most sensitive mechanoreceptors, Merkel's disks and Meissner'scorpuscles, are found in the very top layers of the dermis and epidermisand are generally found in non-hairy skin such as the palms, lips,tongue, soles of feet, fingertips, eyelids, and the face. Merkel's disksare slowly adapting receptors and Meissner's corpuscles are rapidlyadapting receptors so your skin can perceive both when you are touchingsomething and how long the object is touching the skin.

Located deeper in the dermis and along joints, tendons, and muscles areRuffini's corpuscles and Pacinian corpuscles. These mechanoreceptors canfeel sensations such as vibrations traveling down bones and tendons,rotational movement of limbs, and the stretching of skin.

Another type of receptors are thermoreceptors, as their name suggests,these receptors perceive sensations related to the temperature ofobjects the skin feels. They are found in the dermis layer of the skin.There are two basic categories of thermoreceptors: hot and coldreceptors.

Cold receptors start to perceive cold sensations when the surface of theskin drops below 95° F. They are most stimulated when the surface of theskin is at 77° F. and are no longer stimulated when the surface of theskin drops below 41° F. This is why your feet or hands start to go numbwhen they are submerged in icy water for a long period of time.

Hot receptors start to perceive hot sensations when the surface of theskin rises above 86° F. and are most stimulated at 113° F. But beyond113° F., pain receptors take over to avoid damage being done to the skinand underlying tissues.

Thermoreceptors are found all over the body, but cold receptors arefound in greater density than heat receptors. The highest concentrationof thermoreceptors can be found in the face and ears.

Another type of receptor are pain receptors, commonly known asnociceptors, “Noci-” in Latin means “injurious” or “hurt.” Thesereceptors detect pain or stimuli that can or does cause damage to theskin and other tissues of the body. There are over three million painreceptors throughout the body, found in skin, muscles, bones, bloodvessels, and some organs. They can detect pain that is caused bymechanical stimuli (cut or scrape), thermal stimuli (burn), or chemicalstimuli (poison from an insect sting).

These receptors cause a feeling of sharp pain to encourage you toquickly move away from a harmful stimulus such as a broken piece ofglass or a hot stove stop. They also have receptors that cause a dullpain in an area that has been injured to encourage you not to use ortouch that limb or body part until the damaged area has healed. While itis never fun to activate these receptors that cause pain, thesereceptors play an important part in keeping the body safe from seriousinjury or damage by sending these early warning signals to the brain.

Another receptor type are proprioceptors, the word “proprius” means“one's own” and is used in the name of these receptors because theysense the position of the different parts of the body in relation toeach other and the surrounding environment. Proprioceptors are found intendons, muscles, and joint capsules. This location in the body allowsthese special cells to detect changes in muscle length and muscletension. Without proprioceptors, we would not be able to do fundamentalthings such as feeding or clothing ourselves.

While many receptors have specific functions to help us perceivedifferent touch sensations, almost never is just one type active at anyone time. When drinking from a freshly opened can of soda, your hand canperceive many different sensations just by holding it. Thermoreceptorsare sensing that the can is much colder than the surrounding air, whilethe mechanoreceptors in your fingers are feeling the smoothness of thecan and the small fluttering sensations inside the can caused by thecarbon dioxide bubbles rising to the surface of the soda.Mechanoreceptors located deeper in your hand can sense that your hand isstretching around the can, that pressure is being exerted to hold thecan, and that your hand is grasping the can. Proprioceptors are alsosensing the hand stretching as well as how the hand and fingers areholding the can in relation to each other and the rest of the body.

None of the sensations described above and felt by the somatosensorysystem would make any difference if these sensations could not reach thebrain. The nervous system of the body takes up this important task.Neurons, which are specialized nerve cells that are the smallest unit ofthe nervous system, receive and transmit messages with other neurons sothat messages can be sent to and from the brain. This allows the brainto communicate with the body. When your hand touches an object, themechanoreceptors in the skin are activated, and they start a chain ofevents by signaling to the nearest neuron that they touched something.This neuron then transmits this message to the next neuron which getspassed on to the next neuron and on it goes until the message is sent tothe brain. Now the brain can process what your hand touched and sendmessages back to your hand via this same pathway to let the hand know ifthe brain wants more information about the object it is touching or ifthe hand should stop touching it.

Vibration experiments have been conducted to test the effects ofvibration, the results of such an experiment were published in 1961 inthe Journal of Physiol. (1961), 159 pp. 391-409, entitled “Response ofPacinian Corpuscles to Sinousoidal Vibration, by M. Sato. In thisexperiment it was proven that vibrations can excite the nervous systemsimilar to utilization of electrical stimulation.

Other experiments have shown that the 1st Node of Ranvier gaps can beexcited by either mechanical transduction or acoustic stimulation. The1st Node of Ranvier gaps are gaps formed between myelin sheaths betweendifferent cells.

In a 1967 publication entitled “The Relative Sensitivity to Vibration ofMuscle Receptors of the Cat,” M. C. Brown, I. Engberger and P. B. C.Matthews, Journal Physiol. (1967), 192 PP 773-800, the authors testedvibrations and concluded that vibratory effects persist as long as thevibration continues. Additionally, the authors cited anotherpublication, 1966 Matthews, “Reflex excitation of the soleus muscle ofthe decerebrate cat caused by vibration applied to tendon” wherevibration, was applied to a non-contracting muscle, provides a way ofselectively activating nearly all of the nerve fibers from the primaryendings to discharge repetitively. In contrast to electricalstimulation, vibration provides for a more selective activation.

Electrical stimulation will stimulate those nerves which are located inthe close proximity to the electrical source, however, electricalstimulation will seek the lowest resistance pathway and is typicallylocalized to the area of application. In contrast, vibrationalstimulation carries the benefit of exciting afferent fibers at adistance from the location of the application of the vibration.

In 2000 a publication by Alfrey entitled “Characterizing the AfferentLimb of the Baroreflex” Rice University, Houston Tex., April 2000, UMIMicroform 99-69-223. The author concluded that the baroreflex is thefastest autonomic reflex responding to changes in blood pressure.Baroreceptor nerve endings embedded in vessels throughout thecirculatory system encode both mean pressure and rate of change ofpressure as a frequency-modulated train of action potentials (spikes).Centers in the brainstem process the spike train information,integrating it with information from higher centers and providing asignal to the sinoatrial (SA) pacemaking node of the heart via efferentfibers in the vagus nerve. When blood pressure becomes too high, theresulting vagal signal triggers the release of acetylcholine at the SAnode of the heart slowing heart rate and thus lowering blood pressure.

In another paper, published in 2004 by Syntichaki et al., entitled“Genetic Models of Mechanotransduction: The Nematode Caenorhabditiselegans” Physol Rev. 84: 1097-1153, 2004 10.1152/physrev.0043.2003, itwas found that all vertebrates respond to similar mechanosensorystimuli, therefore it's likely that two humans would have similarresponse to the same wavelengths or frequencies.

Lastly, while there are number of different therapies available on themarket and new therapies emerging, there are patient populations thatcannot be treated through the use of the existing drugs or devices.

One such population is patients who develop high blood pressure duringpregnancy. Health care practitioners are generally hesitant toprescribed pharmaceutical products in these situations as there may beunknown side effects to the mother and unborn child. Furthermore, manyhypertensive pharmaceutical products have not been properly tested foruse during pregnancy; therefore, there is much hesitancy on behalf ofthe prescribing physician to use such drug products due to potentialuntested side-effects as well as potential litigation arising from aside-effect. Pregnancy induced hypertension, gestational hypertension orpreeclampsia may not be a permanent condition and may be resolve afterdelivery. Therefore, the use of permanent therapies, such as renaldenervation, may not be warranted in this situation. Additionally,surgical procedures are not generally recommended during pregnancy.

There is yet another hypertensive population emerging in today's worldis the hypertensive adolescent. Over the past 30 years, the number ofadolescent hypertensives has risen to a rate of over 3.7% diagnosedhypertensive and 3.4% diagnosed pre-hypertensive. Only 1 in 4adolescents are currently diagnosed. Many of the currently availablepharmaceutical products have not been tested on an adolescentpopulation, therefore, as described above, many physicians are hesitantto prescribe drug therapies due to unknown side effects or long termeffects they may have. Furthermore, the adolescent population poses yetanother difficulty in that they are still developing and undergoingpuberty and bone growth. Therefore, there is a need for a non-invasive,non-pharmaceutical solution to address this growing patient population.

Thus, it would be desirable to provide improved methods, devices andsystems for artificial and selective activation of a patient'sbaroreflex or nervous system in order to achieve a variety oftherapeutic objectives, including the control of hypertension, renalfunction, heart failure, and the treatment of other cardiovasculardisorders. It would be particularly desirable if such methods andsystems were non-invasive, reversible, safe and/or external to thepatient.

BRIEF DESCRIPTION

In accordance with the present invention there is provided a device fortreatment of hypertension, comprising, a housing, the housing have aproximal end and a distal end; and a driver assembly within the housing,the driver assembly electrically coupled to an energy source, the energysource disposed within the housing.

In accordance with the present invention there is provided a device forimparting energy to a patient, comprising, a housing, the housing havinga proximal end, a distal end and defining a volume therebetween; adriver assembly is disposed within the volume of the housing; an energysource coupled to the driver assembly; and an electronics module coupledto the driver assembly and the energy source, wherein the electronicsmodule controls the driver assembly.

In accordance with the present invention there is provided a device fortreating hypertension, the device comprising, a housing, the housinghaving a proximal surface and a distal surface, wherein the housingfurther includes a mounting system, the mounting system including afirst member and a second member, the first member associated with thehousing and the second member configured to be received by tissue; and adriver assembly within the housing.

In accordance with the present invention this is provided a device forimparting energy to a patient, the device comprising: a housing, thehousing having a first surface and a second surface, the surfacesdefining a volume therebetween, wherein the housing further includes amounting system, the mounting system including a first member and asecond member, the first member associated with the housing and thesecond member configured to be received by tissue; a driver assemblydisposed within the volume of the housing; an energy source coupled tothe driver assembly; and an electronics module coupled to the driverassembly and the energy source.

In accordance with the present invention there is provided a method ofproviding therapy, the method comprising: applying a therapy applyingdevice to a collar bone of a patient; and activating a driver assemblywithin the therapy applying device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exemplary embodiment of the therapy system in accordancewith the present invention;

FIG. 2 is an isometric view of a therapy providing device in accordancewith the present invention;

FIGS. 3A-3D are exemplary illustrations of housings of the therapyproviding device in accordance with the present invention;

FIG. 4A is a top view of a housing of the therapy providing device inaccordance with the present invention;

FIG. 4B is a cross-sectional view of the housing of FIG. 4A taken aboutline B-B;

FIG. 4C is a cross-sectional view of another housing in accordance withthe present invention;

FIG. 5 is an exploded view of a therapy providing device in accordancewith the present invention;

FIG. 6 is an isometric view of a circuit board in accordance with thepresent invention;

FIG. 7 is a plan view of a haptic speaker in accordance with the presentinvention;

FIG. 8 is an isometric view of an electroactive polymer transducer inaccordance with the present invention;

FIG. 9 illustrates a cross-sectional view of the electroactive polymertransducer of FIG. 8 in communication with a driver;

FIG. 10 is a plan view of an alternative embodiment of an electroactivepolymer transducer in accordance with the present invention;

FIG. 11 is an isometric view of a charging/base station in accordancewith the present invention;

FIG. 12 is a side view of the therapy providing device of the presentinvention in combination with a CPAP mask assembly;

FIG. 13A is a bottom view illustrating a therapy device including anadhesive mounting system;

FIG. 13B illustrates the therapy device of FIG. 13A as disposed on auser;

FIGS. 14A and 14B illustrate an alternative mounting arrangement for thetherapy device of the present invention;

FIG. 14C is a cross-sectional view of the mounting system of FIGS. 14Aand 14B;

FIGS. 15A and 15B illustrate another mounting arrangement for thetherapy device of the present invention;

FIGS. 16A and 16B illustrate a magnetic mounting system in accordancewith the present invention;

FIGS. 17 and 18 illustrate embodiments of support structures for usewith the present invention;

FIGS. 19A-19C illustrate another housing in accordance with the presentinvention, the housing configured to be received about a user'sshoulders;

FIGS. 20A and 20B illustrate alternative clothing mounting arrangementsfor the therapy device of the present invention;

FIG. 21A illustrates an exemplary embodiment of a computing device inaccordance with the present invention;

FIG. 21B illustrates and exemplary screen view of a program displayed onthe exemplary computing device of FIG. 21A in accordance with thepresent invention;

FIG. 22 illustrates a flow diagram for a software program in accordancewith the present invention;

FIG. 23A illustrates a therapeutic frequency curve for the therapyprovided by an exemplary embodiment of the present invention;

FIG. 23B illustrates a timed therapy sequence in accordance with anembodiment of the present invention;

FIG. 24A illustrates a patient's blood pressure reading over atwenty-four hour period, showing a hypertensive patient; and

FIG. 24B illustrates the blood pressure of the patient of FIG. 24A afterreceiving therapy in accordance with the device and methods of thepresent invention.

DETAILED DESCRIPTION

The following detailed description illustrates embodiments of theinvention by way of example and not by way of limitation. Thedescription clearly enables one skilled in the art to make and use thedisclosure, describes several embodiments, adaptations, variations,alternatives, and uses of the disclosure, including what is presentlybelieved to be the best mode of carrying out the disclosure.

This written description uses examples to disclose the invention,including the best mode, and also to enable any person skilled in theart to practice the invention, including making and using any devices orsystems and performing any incorporated methods. The patentable scope ofthe invention is defined by the claims, and may include other examplesthat occur to those skilled in the art. Such other examples are intendedto be within the scope of the claims if they have structural elementsthat do not differ from the literal language of the claims, or if theyinclude equivalent structural elements with insubstantial differencesfrom the literal languages of the claims.

In accordance with the present invention there is provided devices andmethods for the treatment of hypertension. The device of the presentinvention is configured to be detachably attached to a user, wherein thedevice is aligned with a bone of the user's body. Once affixed to thepatient, the device can be activated either manually or remotely,wirelessly or wired, through the use of a software program running on acomputing device or a software program within the device. The activationmay be timed to coincide with a patient's sleep pattern, such thattherapy is provided by the device to the patient in the evening andagain in the morning prior to the patient waking up. It is believed thatproviding therapy during a sleep cycle is beneficial.

In accordance with embodiments of the present invention the device isdetachably attached to a patient's tissue and is intended to engage aportion of the patient's skeletal frame, particularly the clavicle. Itshall be understood that although the present invention is described inreference to the collar bone or clavicle, it shall be understood thatthis should not be limiting in any manner. As described above, in apreferred embodiment the methods and devices of the present inventionutilize the clavicle. However, the methods and devices of the presentinvention may be utilized with other dermal bones such as the skull,jawbone, knee cap (patella) or non-dermal bones such as the wrist bone,ribs, scapula. Methods and devices of the present invention can also beused above any portion of the body containing somatory sensors such asproprioceptors, nociceptors, mechanoreceptors or thermoreceptors. Dermalbones are unique in that dermal bone does not form from cartilage firstand then calcify. Dermal bone is formed within the dermis and it growsby accretion only; that is, the outer portion of the bone is depositedby osteocytes. Dermal bones have been utilized to transmit sound forother devices such as in hearing aids.

Referring now to FIG. 1, there is shown the therapy system 100 inaccordance with the present invention. As shown in FIG. 1, the therapysystem 100 in accordance with the present invention may include a pairof therapy providing devices 200 and optionally a computing device 300.The therapy providing system 100 may further include a charging/storagesystem as will be described in detail below with reference to FIG. 11.Additionally, the therapy providing device 200 may further include anintegrated or separate attachment system to detachably attach the system100 to a user's skin as will be described in greater detail below.

As shown in FIG. 1, the computing device 300 in one aspect is configuredto communicate with the therapy providing device 200 through a wirelesscommunication protocol such as through the use of WIFI, BLUETOOTH,ZIGBEE, RFID, NFC, ANT+, cellular, infrared or other known wirelesscommunication protocols. Alternatively, the computing device 300 and thetherapy providing devices 200 may be communicatively coupled togetherusing a physical connection such as an electrical wire, a plurality ofelectrical wires, electrical cable, fiber optic or using other knownphysical connections capable of transmitting signals between thedevices. As shown in FIG. 1, it is contemplated that the methods of usein accordance with the present invention would utilize two therapyproviding devices 200 as shown. If two therapy providing devices 200 areutilized, they are intended to be disposed on a user about the left andright clavicle. In accordance with the present invention a singletherapy providing device 200 may be utilized for treatment according tothe present invention, or multiple therapy providing devices 200 may beutilized for therapy. The two therapy providing devices 200 can becommunicatively coupled together utilizing a physical connection or awireless connection such as those described above.

Referring now to FIG. 2, there is shown an isometric view of a therapyproviding device 200. As shown in FIG. 2, the therapy providing device200 includes a housing 210. The housing 210 defined by a proximal end212 and a distal end 211, and first surface 214 and a second surface 215(not shown), the proximal end, distal end and first and second surfacesand defining a volume therebetween, wherein the volume includesadditional structures and components as will be described below. Asshown in FIG. 2, the first surface 214 includes a power button 260, aLED indicator light 262, and at least one pair of charging pins 265. Themultiple charging pins 265 may be including on the therapy providingdevice 200, whereas the multiple pins 265 are disposed symmetricallyabout an axis (not shown) passing through the power button 260.Placement of the charging pins 265 about an axis extending through thepower button 260 allows for the therapy providing device 200 to beplaced within a charger without care as to orientation as each side ofthe therapy providing device 200 includes charging pins 265, such thatthe therapy providing device 200 will engage the changing pins in thecharging station in either orientation. Additional details with regardto a charging station/base will be described in greater detail belowwith reference to FIG. 11. Additionally, the housing 201 may furtherinclude magnets 230 or a metallic material disposed within recessesformed in the first and second ends 211, 212 of the housing 210.Alternatively, the magnets 230 may be integrally formed with the housing210 during a manufacturing process such as injection molding.

The housing 210 may be formed of multiple pieces which may then beassembled using known assembly methods such as glue, ultrasonic welding,heat welding, rotational welding, snap-fit construction, use offasteners such as screws or pins, or the like. In accordance with theinvention, the housing 210 may be formed of two pieces or multiplepieces, wherein one section of the housing 210 includes all sides exceptthe second surface 215, thereby forming a shell into which thecomponents can be disposed, then the second surface 215 could beattached to the other portion of the housing 210 to form the therapyproviding device 200. The housing 210 may be constructed ofbiocompatible materials such as polymers, plastics, fabrics or metals.The housing 210 may be formed using manufacturing processes such asmachining, injection molding, 3-d printing, vacuum forming, deep drawingor the like. In accordance with the invention, the materials utilized inconstruction of the housing 210 of the therapy providing device 200shall be chosen such that the materials have good biocompatibility as itis intended that the therapy providing device 200 will be placed in skincontact during use, where in certain usages the skin contact may be forprolonged time.

Further still, it is contemplated that the therapy providing device 200may be wrapped with a biocompatible membrane. An example of a suitablemembrane is available from 3M and sold under the tradename of TEGADERM.

Referring now to FIGS. 3A-3D there are shown exemplary embodiment of thesecond surface 215 in accordance with the present invention. As shown inFIG. 3A, the second surface 215 may be formed as a planar surface.Referring now to FIG. 3B, in this figure, the second surface 215 isformed of multiple pieces, wherein one component 216 is configured to bereceived by the other portion of the housing and the second component217 is configured to be received by a user's tissue, this portion 217may be formed of a more pliable or conformable material than the firstcomponent 215, wherein the more pliable material 217 may conform orshape to the user's anatomy more readily. In accordance with theinvention, the second component 217 may be formed of a compliantmaterial such as and open or closed cell foam material, such that whenthe therapy providing device 200 is disposed upon a user for therapy,the compliant foam surface conforms to the user's anatomy. Additionally,the materials selected may be chosen such that they areanti-microbial/bacterial.

Referring now to FIGS. 3C and 3D there is shown another exemplaryembodiment wherein the second surface 218 is shown having a firstthickness, wherein the material of which the first surface 218 is formedis selected such that the material may be shaped or contoured to bereceived by a patient's skin, particularly in an area adjacent thepatient's clavicle. The shaped surface may be in the form of a concaveshape. Further still, the material 218 of FIGS. 3C and 3D may beselected such that the material defines a deformable structure, suchthat when the housing is placed over the patient's clavicle the housingconforms to the patient's anatomy as shown in FIG. 3D. In yet anotherembodiment, a portion of the housing may be custom formed to eachindividual user through the application of heat, whereby the housing ora portion of the housing is heated and then pressed onto the patient,the heated portion of the housing conforming to the patient's anatomy,or heated and molded by through an application of force. In anotheraspect, the second component 217 may be embodied in the form of aflexible membrane in which an expandable foam material may be injectedinto. In use, the therapy providing device would be placed on the userin a chosen location, the expandable foam material could then beinjected into the flexible membrane while the therapy providing deviceis held against the user. As the foam expands and cures, the secondcomponent 217 would take the shape of the user's anatomy, therebyproviding a customized fit. Lastly, it is further contemplated that thehousing includes an enlarged or thickened surface that can be ground ormachined away to conform to the patient's anatomy. Further still, a moldmay be taken of the patient's anatomy, whereby a housing can then bemanufactured from the mold taken from the user's anatomy, therebycustomizing the fit of the therapy providing device to each user.

Referring now to FIGS. 4A-C there are shown additional housing designsin accordance with the present invention. As shown in FIG. 4A thealternative housing is formed in a generally circular fashion, whereinthe housing contains additional components as will be described ingreater detail below. Also as shown in FIG. 4A, the housing 270 mayfurther include a wire or cable connection extending from the housing270 as described above. Referring now to FIG. 4B, there is shown across-sectional view of the housing 270 of the therapy providing device200″ of FIG. 4A taken about line B-B of FIG. 4A. As shown in thecross-sectional view, the alternative housing 270 is formed having agenerally convex shape. Referring now to FIG. 4C there is shown across-sectional view of yet another alternative embodiment of a housing272, in this embodiment the housing 272 has a generally convex shape aspreviously described, however, in this embodiment the housing 272includes concave portions 271. In use, the housing 272 is placed on auser, adjacent to the user's clavicle, wherein a force can be applied tothe housing 272 adjacent to each concave portion 271 forcing air out ofthe concave portions 271, thereby causing a vacuum to be formed therebysuctioning the housing 272 to the user's tissue. It is contemplated thatthe housings 270 and 272 shown in FIGS. 4A-4C may be constructed of abiocompatible flexible material, such that the housing conforms to theuser's anatomy when placed thereupon. Examples of suitable materials ofwhich the housings 270, 272 may be formed from are: silicone, urethanes,rubber, silicone, latex and the like.

Referring now to FIG. 5, there is shown an exploded view of a therapyproviding device 200 in accordance with the present invention. Asdescribed above and shown in FIG. 2-4, the therapy providing deviceincludes a housing 210, wherein the housing includes provisions for apower switch 260 as well as provisions for LED indicators 262 andcharging pins 265 as described above. The power switch 260 maybe aseparate component disposed within the housing 210 or it may be embodiedas a reduced thickness portion (not shown) of the housing 210 which canbe formed to project slightly above the first surface 214 of the housing210, whereby in use, a user can apply a light force to the raisedportion to active a switch disposed beneath the raised portion. Forminga raised portion integral to the first surface of the housing 210 to beutilized as a switch simplifies construction, eliminates additionalcomponents, this construction also eliminates the need to form a holewithin the first surface of the housing which may require sealingagainst liquids. Further, the provisions for the LED 262 and thecharging pins 265 may be in the form of openings formed within thehousing to receive such items. Alternatively, the LED 262 provision maybe embodied in the form of an opaque or clear section within the housing210 during manufacture to allow light to project therethrough from a LED503 mounted on a circuit board 500 disposed below the housing 210.Additionally, it is contemplated that the charging pins 265 may also beintegrally formed during the manufacture of the housing 210. Forexample, if the housing 210 is manufactured using an injection moldingprocess, the charging pins 265 could be disposed within the injectionmold as an insert, whereby the charging pins 265 would be captured inthe housing 210 during the molding process. Alternatively, the housing210 can include openings for charging pins 265 to project through.Further still, the housing 210 may include openings having tapered wallportions, forming pockets within the first surface 214, therebyproviding access to charging pads/pins 504 disposed on a circuit board500 disposed below the first surface 214 of the housing 210. The housing210 may further include an indentation 229 formed therein or a pluralityof indentations 229, allowing a user to grasp the housing 210.

As shown in FIG. 5, the therapy device 200 further includes a firstcircuit board 500 and a second circuit board 550. The first circuitboard 500 is disposed adjacent to the first surface 214 of the housing210, wherein the first circuit board 500 includes a power switchcomponent 502, at least one indicator LED 503 configured to indicate thepower status of the therapy providing device 200. The first circuitboard 500 further includes charging pins/pads 504, wherein the chargingpins/pads may be configured to project through the housing 210 asdescribed above, or alternatively, the housing 210 may include openingsformed therein to access the charging pins/pads 504. The power switch502 may be embodied as a physical switch, such as a slide switch, or maybe embodied as a touch sensitive or capacitive sensitive switch, or maybe embodied as a pressure sensitive switch. The first circuit board 500further includes a connector (not shown) which is configured toelectrically connect the first and second circuit boards. The connectormay be embodied as solder holes in which wires can be disposed into ormay be embodied in the form of a plug or header assemble, wherein theplug/header are configured to accept a cable, wire, ribbon cable or aflexible pcb to facilitate electrical communication between the boards.The first and second circuit boards may be constructed of knownmaterials and methods, whereby the boards may be hard rigid boardassemblies or may be constructed using flexible board manufacturingtechnologies. Although, it is described above that the present inventionutilizes two circuit boards, this should not be considered limiting inany manner, it is contemplated that the electronic components of thepresent invention may be embodied on a single circuit board or onmultiple circuit boards.

As shown in FIG. 5, disposed below the first circuit board 500 is anenergy source 240. The energy source 240 may be in the form of a batterypack. The battery pack may be a rechargeable pack or a single use packwhich may be embodied as gel batteries or absorbed glass mat batteries.Suitable examples of batteries that may comprise the pack are lithiumion (Li-ion), lead-acid, nickel-cadmium (NiCd), nickel-zinc (NiZn),zinc-oxide, nickel metal hydride (NiMH), Lithium ferrous-oxide (LiFo) orother known battery technologies. It is further contemplated thatinstead of utilizing a battery for an energy source a capacitor andrelated circuitry could be utilized.

In the event that the energy source 240 is embodied as a battery pack,the battery pack may be embodied in the form of a fabricated pack, whereindividual cells are soldered together, or alternatively, the batterypack could be arranged to utilize conventional battery sizes such asAAA, AA, CR2032, LR44, 9-volt, A23 and the like.

It is further contemplated that the battery pack may be further dividedinto a primary battery pack and a backup battery pack. In use, theprimary battery would be initially utilized, if the pack malfunctions orloses its charge or its charge is used, the backup battery pack wouldthen be enabled to continue the therapy.

If the battery pack as described above is chosen to be a rechargeable,there is a need to provide a charging circuit within the circuit boards500 or 550. The charging circuit may utilize either a physicalconnection to enable charging or may use a non-contact or inductivecharging arrangement. If a physical connection is utilized, the plug maybe a USB style plug, headphone style, spring loaded pins/contact pads orother types of plugs, such a plug can be integrated into the housing 210and electrically connected to the battery through either circuit board.Alternatively, a plug may be directly mounted onto one of the circuitboards. It is further contemplated that the charging plug can also beutilized both for charging as well as communication between multipletherapy providing devices 200 or the computing module 300 as describedabove using a compatible cable.

As described above, the present invention may utilize pins or padsdisposed on or coupled to the first circuit board to enable charging ofthe battery disposed within the device. It is further contemplated thata non-contact charging assembly could be utilized with the presentinvention. If a non-contact charging arrangement is selected, then thecharging pins 265 and/or openings within the first surface of thehousing 210 may not be necessary. Instead, the therapy providing device200 would include a charging coil (not shown) disposed about theperimeter of the first circuit board 500. The use of a non-contactcharging coil would further necessitate the inclusion of additionalintegrated circuits to enable and control the charging function. Theseadditional circuits can be disposed on either of the two circuit boards.Suitable examples of a non-conductive or inductive charging wouldutilize an electromagnetic field to transfer energy between the chargerand the battery pack. In this embodiment a charging station would beprovided in which the therapy providing device 200 could be stored andcharged simultaneously as will be described below. It is alsocontemplated that the storage/charging container may be a smartcontainer that is it may contain a microprocessor and/or a wirelesscommunication chipset. Thus, once the therapy device is removed from thestorage container, the integrated wireless chipset within the storagecontainer may cause the therapy device to power on. Suitable examples ofcomponents to enable non-contact charging are available from WurthElectronics Inc., part numbers 760308201 wireless charging receivingcoil and 760308101 wireless charging transmitting coil.

In accordance with the present invention, it is contemplated that theenergy source 240 may be embodied in the form of an integratedgenerator, wherein the generator would be configured to create energyfrom movement of the therapy providing device 200, much like andautomatic watch movement.

As described above, the therapy providing device 200 shown in FIG. 5includes two circuit boards, 500 and 550. The circuit board 500 havingbeen previously described above. Referring now to FIGS. 5 and 6 thereare shown exemplary embodiments of the circuit board 550 in accordancewith the therapy providing device 200 of the present invention. Asdescribed above, the second circuit board 550 is configured to becoupled with the first circuit board 500, wherein components may bedisposed on either of the two boards and interconnected through anappropriate connection as previously described using a header or solderholes formed in the circuit board 550. Referring now to FIG. 6, there isshown a general schematic of the second circuit board 550, wherein thesecond circuit board 550 includes a processor 551, optional memory chip552, an audio amplification circuit 553 and a communication port 554.The communication port 554 may embodied as a physical port such as amini-usb, micro-usb, firewire, thunderbolt or other known similarcommunication ports. The audio amplification circuit 553 may include oneor two audio amplifiers, wherein the incoming signal from the processor551 is amplified such that the amplified signal can then be connected toa driver assembly 220 as described below. As shown in FIGS. 5 and 6, thesecond circuit board 550 may be shaped to be received within a shapedhousing. As shown in FIGS. 5 and 6, the second circuit board is shownhaving an elliptical shape with an aperture formed through the centerthereof. The aperture can be sized to receive a portion of the driverassembly 220, thereby allowing the overall size of the device to bereduced by allowing components to ‘nest’ when assembled. The secondcircuit board 550 may contain additional electronic components such asaudio filters, booster circuits, timing circuit and data loggingcapability. In accordance with the present invention, the processor 551may be sourced from CSR PLC, Churchill House, Cambridge Business Park,Cowley Road, Cambridge, CB4 0WZ Churchill House, Cambridge BusinessPark, Cowley Road, Cambridge, CB4 0WZ, having part number 8670.

The second circuit board 550 may further include a communicationschipset (not shown) such: BLUETOOTH, WIFI, ZIGBEE, RFID, NFC, Ant+,infrared, 3G/4G, CDMA, TDMA or other known wireless communicationprotocols.

The first or second circuit board 500/550 may further include a clockcircuit (not shown). The clock circuit generates and sets the timing ofoperations performing within the therapy providing device 200. The clockgenerator may be utilized to activate the therapy providing device 200,or may be utilized to record timed events, such as when the therapyproviding device is on or off or in use.

Further still, either circuit board 500/550 may alternatively include animpedance sensor or pair of impedance sensors, the impedance sensors inassociation with the processor 551 can be used to determine if thehousing 210 is coupled to a user's skin or if the housing is not coupledto the skin. If the housing 210 is coupled to a user's skin, then theimpedance sensor would provide a signal to the processor 551 indicatingsuch a condition, thereby the program stored in the memory of theprocessor or transmitted to the microprocessor could be initiated toconduct therapy according to the invention. If the impedance sensor isnot coupled to the user's skin, then an open condition would occur,whereby the program would not be initiated and a visual signal may begenerated through the program/processor to alert the user that thetherapy providing device 200 is not placed properly and needs to berepositioned.

In yet another embodiment, the electronics module may include amicrophone, whereby a test signal can be initiated and delivered by thedriver assembly 220 or other audio/vibration device. The microphonewould be utilized by the processor 551 to listen for a reflection of thetest signal off of the user's clavicle, skin or other bone or structureto determine if the therapy providing device 200 has been placedproperly. If the reflected sound matches that of one stored in memory,then the program can be run to provide therapy. If the reflected sounddoes not match the sound stored in memory, then an error message wouldbe generated. The error message may be in the form of an audio signal orin the form of a visual signal such as a blinking light or a series ofblinking lights.

Additionally, the microphone could be coupled with a blood pressuremonitor, wherein the microphone would listen for Korotkoff sounds,whereby the data generated from the blood pressure monitor andspecifically the Korotkoff sounds captured by the microphone can beutilized to enable a closed loop control system or closed loop feedbacksystem. It is contemplated, that the therapy provided by the therapyproviding device 200 can be dynamically modified in response to the datareceived from the microphone coupled to the processor 551.

The circuit board 500 or 550 may further incorporate a pressuresensitive switch coupled to the processor 551. In use, the pressuresensitive switch would be in a normally open position or off position.When the therapy providing device 200 is placed on the user's skin, thepressure sensitive switch would be depressed, thereby turning thetherapy providing device 200 on. The actuation of the switch can also beassociated with the clock circuit to associate a time with the on/offstate of the switch. These events can be written to the memory of theprocessor 551 or other memory storage location. The data can then betransmitted, wired or wirelessly, to a personal computer foranalysis/storage. By tracking the actual on/off time of the therapyproviding device, user compliance may be tracked by the user or by athird party such as a health care provider.

In yet another embodiment, the circuit board 500 or 550 may include anoptical sensor, wherein the optical sensor is utilized to detect whetherthe therapy providing device is affixed to a user's skin. In thisembodiment, the optical sensor can include a light sensor, whereby whenthe therapy providing device 200 is affixed to the user's skin the lightis blocked to the sensor. In another embodiment, the optical sensor canbe a reflective sensor, wherein the color of the light reflected backindicates whether the device is affixed to a user's skin or not.

In another aspect of the present invention, the light sensor may beutilized to monitoring blood oxygen level, wherein data received frommonitoring the user's blood oxygen level can be stored in memory ortransmitted to another device such as a pulse-oximetry monitor oranother computing device. Further still, the blood oxygen data may beutilized by a program of the therapy providing device to alter therapyprovided to the user or otherwise control the therapy providing device200.

In another aspect of the present invention, the light sensor may be usedto measure alteration in blood-reflectance color, whereby the programcontrolling the therapy providing device may utilize this signal as arepresentation of heart rate or heartbeat. Accordingly the programcontrolling the therapy providing device 200 may use this data todetermine blood pressure and accordingly provide therapy to the userbased on the received data.

It is further contemplated, that an accelerometer and/or compass and/ortilt sensor and/or GPS sensor can be incorporated into either of thecircuit boards described above. The inclusion of such a sensor can beutilized to determine the position and/or orientation of the device. Inuse, as described below, a user would affix the housing 210 to theirperson using an adhesive patch, harness, specialized clothing article aswill be described below. In this embodiment, the accelerometer/compassin communication with the processor 551 can be utilized to determinewhen to activate the therapy providing device or devices 200. If thesignal coming back from the accelerometer/compass/tilt sensor indicatesthat a therapy providing device 200 is in a vertical position, then theprogram contained within the memory of the processor 551 or computingdevice 800 would not be initiated. Once the signal from theaccelerometer/compass/tilt/GPS sensor indicates that the user is in aprone position, likely a sleep position, then the program containedwithin the memory can be run. Additionally, the clock timer can beassociated with the accelerometer/compass/tilt/GPS sensor such that auser's sleep pattern can be stored in memory of the processor 551 orcomputing device 800. Data generated from such sensors could be storedin memory, of either the therapy providing device or the computingdevice to track usage of the device as well as the physical location ofthe devices. Such data could be transmitted to a third party using knowwireless communication methods.

The circuit boards or the housing or therapy providing device 200 may beprovided with a unique identifier such as a serial number or patientinformation identifier so that the therapy providing device 200 may betracked. Additionally, using the unique identifier it may be possiblefor a physician or a user to utilize a computer program, such as awebsite which when placed in communication with the therapy providingdevice, either wired or wirelessly, would allow continuous monitoring ofusage of the device, such as date and time monitoring, duration of use,patient compliance and the like. The website could also provideinformation regarding hypertension and additionally be configured tocommunicate with other devices such as a scale to track the user'sweight, a blood pressure monitor to track blood pressure measurements, aglucose meter, a heart rate monitor or other fitness tracking devicesuch as FITBIT or BODYBUG. Each of these devices would be interfacedwith the website, such that data collected from these devices could beuploaded to the website where the data could be presented to the user oralternatively, the data could be shared with anyone that the userchooses to do so. For example, the user may desire to share the datawith their health care provider, dietician or other individual(s).

In accordance with the invention, it is contemplated that one or bothcircuit boards along with the battery may be housed within a separatehousing from the therapy providing device 200. In this embodiment, thecircuit board(s) and battery would be coupled to the therapy providingdevice either through a cable connection or through a wirelessconnection. If a wireless connection is utilized, then the therapyproviding device would include the necessary electronics disposed withinits housing to facilitate the communication between the electronicsmodule and the therapy providing device as well as a power source suchas the battery.

Referring to FIG. 5, disposed below the second circuit board 550 is adriver assembly 220. The driver assembly 220 is disposed within thevolume 213 of the housing 210. The driver assembly may comprise aconventional coil speaker, an ultrasonic generator, a piezoelectricspeaker, a haptic speaker, a pneumatic device, a suction device, amechanical vibratory device, a hydraulic actuation device, or aphoto-acoustic excitation device. Examples of drivers assemblies 220that can be used with the present invention may be purchased from HiWaveTechnologies PLC, Regus House, 1010 Cambourne Business Park, Cambourne,Cambridge CB23 6DP United Kingdom. Referring now to FIG. 7 there isshown an exemplary haptic speaker or haptic exciter 220′ which may beutilized with the therapy providing device 200 of the present invention.As shown in FIG. 7, the haptic speaker 220′ includes a frame member 221,a voice coil 222 and a plurality of flexible members 223. Additionally,the haptic speaker 220′ includes electrical connections 224, therebyallowing the haptic speaker 220′ to be electrically connected to theaudio amplifier circuit as previously described. In use, the flexiblemembers 223 allow the voice coil 222 of the haptic speaker 220′ totranslate relative to the frame 221, thereby producing sound ormovement.

In yet another embodiment, the driver assembly 220 may be embodied as anelectroactive polymer transducer 315 as shown in FIGS. 8-10.Electroactive polymer transducers are made up of a first thin elasticpolymer 320, which is also referred to as a film or membrane, this issandwiched between compliant electrodes 340 and 345. When voltage isapplied across the electrodes, the unlike charges in the two electrodesare attracted to each other, these electrostatic attractive forcescompress the polymer film 320 (along the z-axis). The repulsive forcesbetween like charges in each electrode stretch the film in the plane(along the X and Y axis'). As the transducer 315 deflects, thedeflection can be utilized to perform work. In the present invention,the work that is performed is the development of vibrations, wherein thevibrations being developed by the transducer 315 are developed within acertain frequency range as will be discussed in greater detail below.Additional information regarding electrostatic transducers can be foundin U.S. Pat. No. 7,898,159 and U.S. Pat. No. 7,608,989, the entiretiesof which are hereby incorporated by reference.

It is further contemplated that the transducer 315 as described abovemay be further coupled to another assembly, wherein the other assemblywould have an increased mass. Through use, the transducer would beactivated by providing a voltage to the electrodes, thereby exciting thepolymer, wherein the weighted assembly would be excited therebydelivering greater vibrational energy.

In accordance with another aspect of the present invention, theelectroactive polymer transducer 315 can be formed to have a curvedshape, or be attached to a housing having a curved shape, such that thehousing or curved excited can be readily received by a user's anatomy,specifically the user's clavicle or collarbone.

The electroactive polymer transducer 315 of the present invention may beembodied in different geometric shapes. It is contemplated that thetransducer 315 may be embodied in the form a circular shape, oblongshape, square, rectangular or other known geometric shapes. Furtherstill, it is contemplated that the transducer may be formed with atleast one bar-arm type of arrangement as shown in FIG. 3D. In thisembodiment, the bar-arm 347 is configured to vibrate in response to thecharge placed on the electrodes. The number of bars and shape of thebars can be configured to adjust the acoustic/vibrational properties ofthe assembly.

Use of an electroactive polymer transducer as described above furtherincludes a circuit driver 350, the circuit driver 350 may beincorporated into the first or second circuit boards 500/550 asdescribed above. Alternatively, the circuit driver 350 may be embodiedas a separate circuit board (not shown) which may be electricallycoupled with either the first or second circuit boards of the presentinvention. The circuit driver 350 further includes an audio input 360and at least one output 370, but preferably a pair of outputs 371 and372. The outputs 371, 372 are coupled to the electrodes 340, 345 of thetransducer 315.

The circuit driver 350, may further include additional components suchas an amplifier, a filter, a voltage step-up circuit, a chargecontroller, voltage step-down.

Further still it is contemplated that the driver assembly may beembodied as multiple elements, for example any combination of driverassemblies may be use, such as a combination of a haptic speaker and apiezo, a haptic speaker and an electro active polymer transducer, anelectroactive polymer transducer and a piezo or multiples of the samedriver type within the same housing. The examples provided herein shouldnot be considered limiting in any manner. Alternatively, the driverassembly may be a vibrating motor or coin cell motor.

As described above and in accordance with the present invention, it iscontemplated that two therapy providing devices 200 may be utilizedtogether to provide therapy to a user, wherein the two therapy units maybe interconnected with a physical connection. It is contemplated thatone of the therapy devices may have a complete set of electronicsdisposed therein, wherein the complete set of electronics would includethe communication, memory and other chipset(s) and associated circuitry.Wherein the other therapy providing module 200 could then include asimplified electronics module, wherein the simplified electronics modulewould not have the complete chipset of the complete electronics module.For example, the simplified electronics module would not need to have abattery charging circuit or other chips as well it may have less or nomemory. By providing the other therapy providing device with a slimmeddown electronics module a larger energy source may be fitted, throughthis arrangement the combined therapy providing devices 200 could beutilized for a longer time before the energy source would need to bereplaced or recharged.

Referring now to FIG. 11 there is shown a charging/base station 570 inaccordance with the present invention. As shown in FIG. 11, the basestation 570 includes a housing 571, wherein the housing 571 includesrecessed portions 572 configured to receive the therapy providing device200 therein. The recessed portions 572 are configured to includecharging pins 574, which when the therapy providing device 200 isdisposed within the recess will align with the charging pins/pads 265 ofthe therapy providing device. In addition to the charging pins 574,other pins may be included both on the base 570 and the therapyproviding device 200 which may be used for other purposes such asdownloading data stored within memory of the therapy providing device(s)200. The base station 570 may further include a wired or wirelessconnection to the internet or other network such that the data receivedfrom the therapy providing device(s) can be transmitted or uploaded to awebpage as described above or transmitted to another location such as ahealth care provider or other location for storage. It is furthercontemplated that the base 570 may include additional features such asan alarm clock or clock 573, a cellular telephone or tablet chargingstation. As will be described in greater detail below with regard toFIGS. 16A and 16B, the therapy providing device may include extensions219 extending from the housing 210 each extension 219 containing amagnet 230. It is contemplated that the recessed portions of thecharging base 570 may be shaped to receive the extensions 219 of thehousing 210 shown in FIG. 16A. The recessed portions 572 may be adaptedto receive the extensions 219 or may further include a metallic memberor a magnet disposed therein, such that when the therapy providingdevice is placed into the recessed portion, the magnets 230 within thehousing 210 of the therapy providing device 200 are attracted to themetal or magnet of the charging station 570, thus, temporarily affixingthe therapy providing device 200 to the charging station. In addition totemporarily affixing the therapy providing device 200 to the chargingstation 570, by temporarily affixing the therapy providing device 200 tothe charging/base station 570 providing better contact between thetherapy providing device 200 and the charging pins 574. It iscontemplated that other arrangements to increase contact between thetherapy providing device and the charging pins of the charging/basestation may be utilized. For example, the charging pins 574 in the basestation 570 may be configured to move linearly and be held with a springforce, whereby the charging pins 574 retract or partially retract when atherapy providing device 200 is placed into the recessed portion 572 forcharging. Additionally, another member (not shown), such as a plate orweights may be placed onto the therapy providing devices after thetherapy providing devices have been disposed within the recessedportions. Further still, the charging pins 574 may be disposed on a lid(not shown) of the charging base 570, such that the therapy providingdevice 200 is placed within a recessed portion 572 of the charging base570 and the lid is closed, thereby completing the electrical connectionbetween the charging pins 574 of the charging base and the chargingpins/pads 256 of the therapy providing device 200.

In accordance with the invention, the base 570 may be further embodiedas another medical device or incorporate other medical devices. It iscontemplated that the base 570 may incorporate, or be incorporated intoanother medical device such as a pulse-oximetry meter, a blood pressuremonitoring device, a glucose meter, an infusion pump, a glucose pump,sleep tracking device, temperature measuring device, or a sleep apneadevice such as those offered by ResMed and Respironics. Presently, sleepapnea devices utilize a console which houses the electronics necessaryto control a blower to deliver pressurized air to a patient interface.The patient interface may be embodied in the form of a full-face mask,nasal mask, oro-nasal mask, mouth mask, nasal prongs, or other suitableconfigurations know in the art. Also, any suitable headgear arrangementsmay be utilized to comfortably support the patient interface in adesired position.

In yet another aspect of the present invention, referring now to FIG. 12there is shown the therapy providing device 200 of the presentinvention, wherein the therapy providing device 200 has been adapted tointerface with a sleep apnea patient interface. As shown in FIG. 12, thetherapy providing device 200 is configured to be received or engage oris integrated into the headgear arrangement of a sleep apnea patientinterface device, wherein the therapy providing device of the presentinvention is configured to engage the patient's jawbone or skull.

In yet another aspect of the present invention, the therapy providingdevice 200 may be incorporated into other devices which are configuredto engage a patient's tissue and skeletal bones such as bone conductionhearing aids, one such example is being offered by Sonitus Medical underthe tradename SOUNDBITE.

Referring now to FIGS. 13A, 14A, 14B, 15A, 15B, 16A and 16B there areshown multiple embodiments of the housing 210 of the therapy providingdevice 200 in accordance with the present invention. As shown in thesefigures, the housing 210 is shown having a variety of mountingassemblies that can be utilized to affix the therapy providing device200 to the patient.

As shown in FIG. 13A, one surface of the therapy providing device isprovided with a slot 263. A bandage 265 can be passed through the slot263, wherein a rib 261 formed by slot 263 retains the therapy providingdevice 200 onto the bandage 265. The bandage 265 further includes abiocompatible adhesive, such that the therapy providing device 200 canbe affixed to the patient as shown in FIG. 13B. The bandage may be aone-time use construction, wherein the bandage is disposed of after asingle use. Alternatively, the bandage 265 may be a multiple-useproduct, wherein the biocompatible adhesive is selected such that thebandage can be placed and removed from a user's skin multiple times.Additionally, it is contemplated that the biocompatible adhesive may berenewed. The adhesive may be renewed by spreading new adhesive over theexisting adhesive, washing the adhesive surface with a substance torenew the surface or the adhesive may be embodied having multiple thinlayers, wherein the user removes the used layers and disposes of theused layer, thereby exposing a new layer of adhesive for use again. Asuitable example of an adhesive for a reusable bandage are hydrogeladhesives, similar to those utilized on electrodes for electrical musclestimulation devices, otherwise known as a TENS unit. Such electrodes aremanufactured and sold by 3M as well as others. It is contemplated, thata temporary marking may be applied to the user's body initially toindicate the location of where the therapy providing device. Forexample, the temporary marking may be in the form of a temporary tattooor a henna tattoo.

Alternatively, a bandage large enough to cover the entire housing of thetherapy providing device 200 may be utilized. In this embodiment, thebandage would hang over the edge of the housing by a sufficient amount,such that when the therapy providing device 200 is placed against thetissue of the user, the bandage could be affixed to the tissue to holdthe therapy providing device in a desired position. In this embodiment,the bandage may include an aperture, an opaque section or otherwisetransparent section, such that when the bandage is placed over thetherapy providing device 200, the button 260, LEDs 262 and chargingpins/ports 265 on the top surface of the housing 210 of the therapyproviding device 200 described above are visible and accessible if thehousing includes such components. Such a bandage may be constructed tofurther include a one-way membrane, wherein moisture under the bandagemay be transported or migrate from the tissue surface through thebandage, however, the bandage would not allow fluid to pass from theoutside to the therapy providing device 200 or the user's tissue.

Referring now to FIGS. 14A-14C there is shown an alternative design foraffixing the therapy providing device 200 to the patient. In thisembodiment, one surface of the therapy providing device includes a firstfitting 280 disposed on the second surface 215 of the housing 210. Abandage 400 is provided, wherein the bandage 400 has a proximal surface402 and a distal surface 401. A biocompatible adhesive is disposed onthe distal surface of the bandage 401. A second fitting 281 is disposedon the proximal surface 402 of the bandage 400. The first fitting 280and the second fitting 281 are designed to be received by each other andto form a detachable locking attachment as shown in FIG. 14C. Suitableexamples of such detachable fittings may be a screw thread, quarter turnfasteners, grooved pathways, a tapered fitting and the like. A safetylock (not shown) may be incorporated into either of the fittings,wherein the safety lock would engage after the two fittings are broughttogether in a locking arrangement. The safety lock would prevent thefittings from releasing without an additional application of force ormotion to the safety lock to enable the fittings to be separated. Thebandage 400 may be a single use product or may be a re-usable bandage asdescribed above. In another aspect, the bandage of the present inventionmay be fabricated to include multiple layers, wherein each layerincludes a new glue surface. After use, the layer of the bandage havingbeen in contact with tissue is peeled off by the user and properlydisposed of, thereby exposing a new glue layer for further use.

Referring now to FIGS. 15A and 15B there is shown another alternativedesign for affixing the therapy device 200 to a patient. In thisembodiment, a surface of the therapy device 200 includes a magnet 290disposed thereon or incorporated into the surface. As described abovebandage 400 is provided, wherein the bandage 400 has a proximal surface402 and a distal surface 401. A biocompatible adhesive is disposed onthe distal surface of the bandage 401. A metallic member 292 isincorporated into the bandage 400 as shown in FIG. 15B. In use, the userwould apply the bandage 400 to their body, wherein the center of thebandage would align with their clavicle. In one embodiment, the bandage400 would be replaced daily. In another embodiment, the bandage 400would be reused for a period of time and then replaced. Further still,in another embodiment, the glue surface of the bandage 400 may berefurbished after each use to prolong the useful life of the bandage400. Once the bandage 400 is affixed to the user, the therapy providingdevice 200 as shown in FIG. 15A and described above would then becoupled to the bandage through the magnetic coupling between the magnet290 of the therapy providing device 200 and the metallic member 292 ofthe bandage 400. It shall be understood that the combination of using amagnet 290 and a metallic member 292 could be reversed. For example, thebandage 400 may contain the magnet 290 and the therapy providing device200 would have the metallic member 292. Alternatively, both the bandage400 and the therapy providing device 200 may include a magnet 290,whereby the magnets 290 assist in self-aligning the therapy providingdevice to the bandage 400. Further still, it is contemplated that themagnet or metallic member of either the bandage 400 or the therapyproviding device 200 may be offset from an axis extending through thecenter of the bandage 400, thereby providing for two differentorientations in which the therapy providing device 200 may disposed uponthe bandage 400 in for use. Further still, it is contemplated that thedriver 220 of the therapy providing device may be offset within thehousing 210 from an axis running longitudinally through the housing 210.Offsetting the driver 220 within the housing 210, achieves the sameeffect of providing multiple mounting orientations of the therapyproviding device 200 during use. In yet another embodiment, the magnet290 or metallic member 292 could be implanted under the user's skin,therefore eliminating the need for the bandage 400. In this embodiment,the therapy providing device 200 could be coupled to the patient's skindirectly.

In another embodiment (not shown) the bandage may include an apertureformed therethrough, wherein the metallic member 292 would be disposedabout the aperture. The aperture is sized to receive a portion of thetherapy providing device 200 therein. It is further contemplated thatthe therapy providing device may include a second bandage or an enlargedsurface similar in size to the bandage 400. The enlarged surface wouldcontain magnets 290 as described above; therefore, when the therapyproviding device 200 is disposed within the aperture of the bandage 400,the enlarged surface covers the bandage.

In further embodiments, the magnets and the metallic members may beinterchanged, wherein the bandage contains the magnets and the housingmay be a metallic member, a portion may be metallic or a portion may bemagnetic. Additionally, instead of utilizing magnets and metallicmembers, other known detachable systems may be utilized, for example ahook and loop configuration or reusable adhesive surface.

Referring now to FIGS. 16A and 16B there is shown a housing inaccordance with the present invention, wherein the housing 210 includesextensions 219. The extensions 219 further include magnets 230 disposedtherein. Referring now to FIG. 16B there is shown a bandage 420 to beutilized with the housing shown in FIG. 16A. The bandage 420 furtherincludes an aperture 431 formed therethrough, the aperture sized toaccept a portion of the therapy providing device 200. The bandage 420further includes magnets 430 disposed therein. The bandage 420 may beformed of a multilayer construction, wherein the bandage may include aglue layer a glue support layer and a backing layer. It is contemplatedthat the magnets 430 could be disposed within the glue support layer,wherein the magnets 430 would be encapsulated in the bandage 420 by theglue layer and the backing layer. In use, the user would place thebandage 420 onto their skin, wherein the user can use the aperture 431to properly align the bandage in the example where the therapy providingdevice is placed over the clavicle. The glue layer of the bandage 420may be a re-usable adhesive, such as that described above and commonlyutilized on tens electrodes, wherein the glue layer allows forrepositioning of the bandage. After placement of the bandage 420, thetherapy providing device, having a housing shown in FIG. 16A is disposedover the bandage. The magnets 230 of the housing extensions 219 and themagnets 430 of the bandage act to attach and center the therapyproviding device to the bandage. In accordance with the invention, it iscontemplated that either the magnets 230 of the housing or the magnets430 of the bandage may be replaced by metallic members.

In yet another aspect of the invention, as described herein the magnets,which may be positioned in the device housing, the bandage or both, maybe utilized to control the function of the therapy providing device 200.In this example, at least one of the magnets can be used as a switch tocontrol or complete a power circuit. The power circuit can be activatedsuch as to power the therapy providing device 200 on, thereby initiatingtherapy. If the magnetic connection is broken, then the therapyproviding device would be powered off. It is further contemplated, thatin addition to the above, the magnet within the device or bandage may bemanufactured with specific properties, such that the therapy providingdevice will only operate with original equipment manufacturing products,thereby preventing the therapy providing device 200 from being utilizedwith non-approved or counterfeit bandages. A benefit of utilizing themagnets to switch the device on/off is that the user does not have toactivate any buttons on the device, additionally, the device can besimplified through the eliminate of the button on the therapy providingdevice as described herein. Another benefit is the preservation ofbattery life of the device, as the device will be powered off as soon asthe magnetic connection is broken. Additionally, if the therapyproviding device is being utilized at night time during sleep and thedevice becomes dislodged from the user, the device will automaticallypower off, thus providing an additional safety feature.

Further still, it is contemplated, that the therapy providing device 200and/or bandage may include a security feature, such as an opticalscanner disposed within the therapy providing device, such that theoptical scanner is configured to scan a QR code, bar code or other codedprinted on the bandage or bandage packaging. As described above, thiscombination of a scanner and specific code can be utilized to controlthe activation of the therapy providing device 200. Additionally, theuse of a security code/barcode can be combined with the magneticactivation of the therapy providing device 200 as described above toensure that the bandage being utilized is an approved product that hasbeen designed to be specifically utilized with the therapy providingdevice 200 and that the bandage is not a third-party un-approved productor a counterfeit product. It is contemplated that other types ofsecurity systems can be utilized to achieve the same or similarfunctions. For example, the bandage may include a protrusion (not shown)that projects above the surface of the bandage, the protrusion would bereceived within an aperture of the second surface of the housing whereit would activate a switch within the housing. Another example would bethe use of an electronic circuit or chip disposed upon or within thebandage, the circuit or chip would interface with the therapy providingdevice, thereby completing a circuit to enable activation of the therapyproviding device.

Referring now to FIG. 17 there is shown an alternative design for amounting device to be utilized with the therapy system 100 in accordancewith the present invention. As shown in FIG. 17 there is shown a supportstructure 600. The support structure 600 can be configured to positiontherapy providing devices 200 according to the present invention in apreferred location over a user's clavicle. The user can also adjust thepositioning of the location of the therapy providing devices 200 byadjusting both the angle of the arm about pivot 610 and buy adjustingthe length through the telescoping assembly 620.

The support structure 600 further includes a ball and cup joint 660 atthe distal ends 640 of the arms 630. The ball and cup joint 660 isarranged to hold the therapy providing device 200 and allows a user toalign the therapy providing device 200 substantially parallel to asurface of the user at the desired location to insure that as much aspossible of the therapy providing device 200 is in contact with theuser.

The support structure 600 further includes a pad 650 connected to thearms 630. In accordance with embodiments of the present invention, thepad may contain the electronics module 320 and the power source.

The arms 630 of the support structure 600 can also be configured toinclude a spring force to push the therapy providing device 200 againstthe body. For example, the arms 630 of the support structure 600depicted in FIG. 17 are curved and are configured to apply a springforce between the therapy providing units 200 and the pad 650 when thesupport structure 600 is placed over a user's shoulders.

Referring now to FIG. 18 there is shown another example, of a supportstructure 700 in accordance with the present invention. As shown in FIG.4H, the support structure 700 includes a pad 750, a first arm 730, andsecond arms 731. The support structure 700 further includes joints 740,the joints 740 join the first arm 730 to the second arms 731. The joints740 are configured to allow for rotational motion between the first arm730 and the second arms 731 in order to allow a user to align thetherapy providing devices 200 in accordance with the methods of thepresent invention. The second arms 731 further include telescopingsections 745. The telescoping sections 745 allow the user to adjust thelength of the second arms 731 to position the therapy providing unitsproperly. The second arms 731 further include a ball joint assembly 760disposed at their distal ends, the ball joint assemblies 760 couple thetherapy providing units to the second arms 731. The ball jointassemblies 760 allow the therapy providing units to lay flat against theuser's collar bones and account for differences in anatomy. The supportstructure 700 further includes a pad 750 coupled to the first arm 730.As described above the pad 750 may contain the electronics module 320and the power source. In certain embodiments the electronics module andpower source would be user replaceable. In other embodiments, theelectronics module and battery would not be user replaceable and theentire assembly would be replaced including the therapy providingdevices.

The support structures 600 and 700 can be made of an elastic material.The elasticity of the design provides for a spring or clamping force,such that the support structure and therapy providing devices remain inposition during use.

The support structures described herein can be configured to fit snuglywithout being too compressive on the body, are straightforward to put onover the shoulders or around the torso, and can be worn underneathclothing without significantly altering the profile of the clothing.

Referring now to FIGS. 19A-19C, there are shown additional embodimentsof the present invention. As shown in FIGS. 19A-19C, the therapyproviding device 200 of the present invention may be incorporated into asupport structure 800, wherein the support structure 800 includes aproximal end 802 and a distal end 801 and an elongate member 803extending between the two ends. The support structure further includes acontrol panel 810, wherein the control panel 810 may include anindicator such as a light or LED 811 to indicate the function of thetherapy providing devices 200. The control panel 810 further includes aswitch 813, the switch 813 being in electrical communication with thetherapy providing devices 200 and the electronics module 230 and theenergy source 240, each of which have been described above. The supportstructure 800 may be fabricated of fabric such as cotton, nylon,polyester or the like, wherein the body 803 is in the form of a tubular,square, rectangular or cylindrical shape, thereby forming an innerchamber. As shown in FIG. 19A, the therapy providing devices 200 and theelectronics module 230 and energy source 240 are shown disposed withinthe inner chamber. These components may be held within the inner chamberthrough the use of pockets formed within the inner chamber. It isfurther contemplated that the inner chamber may be filled with amaterial to increase the weight of the overall device. Examples ofmaterials that can be utilized to fill the chamber are rice, beans,sand, metallic materials, polymer materials and other such materialsthat are known to one skilled in the art.

As shown in FIGS. 19B and 19C, the support structure 800 can be wornaround a user's neck and shoulders, wherein the therapy providing device200 would be adjusted by the user to fall onto and make contact with theuser's clavicle. The support structure 800 may be disposed over the topof a user's clothing as shown in FIG. 19B, or alternatively the supportstructure 800 may be disposed directly against a user's skin as shown inFIG. 19C.

In accordance with the embodiment shown in FIGS. 19A-19C, it iscontemplated that the support structure may further include a removablecover (not shown), wherein the removable cover can be disposed about thesupport structure 800. The removable cover may include a zipper, velcroor snaps to open and close the cover. Additionally, the removable covermay include additional items such as pads placed along a portion or alength thereof. For example, a pad may be disposed on the cover near theuser's neck area.

It is further contemplated that the support structure 800 in accordancewith the present invention may include additional features. For example,a heating element may be incorporated into the support structure 800,whereby the heating element may be utilized by the user to address soremuscles or neck pain.

Referring now to FIGS. 20A and 20B, there are shown exemplaryembodiments of clothing articles which can be utilized with the therapyproviding device 200 of the present invention.

As shown in FIG. 20A, in one embodiment, the clothing article isembodied as a t-shirt 600, wherein the t-shirt 600 includes pockets 602formed therein to receive the therapy providing device 200. The pockets602 are aligned over the user's clavicle in order to provide treatmentas will be described below.

Referring now to FIG. 20B there is shown an alternative embodiment of apiece of clothing configured to retain the therapy device 200 inaccordance with the present invention. As shown in FIG. 5B the clothingcan be embodied in the form of a sports bra 610. The sports bra 610further includes pockets 612 configured to receive the therapy device200. Alternatively, instead of pockets, other attachment mechanisms suchas those described above, wherein instead of pockets, magnets, hook andloop fasteners, snap fasteners, twist and lock or similar types offastening systems may be utilized to retain the therapy providing device200 in position.

Additionally, the clothing devices described above may further includean additional pocket or pockets to receive the computing device, or inembodiments wherein the electronics or energy source are separate fromthe therapy providing device, pockets or other retention means to retainthese additional components.

The clothing devices may further include a structure formed therein orattached thereto (not shown) wherein the structure is configured toapply a downward force upon the therapy providing device(s). Structuressimilar to those shown in FIGS. 17, 18 and 19 may be utilized.

In accordance with the present invention, the therapy providing device200 may include addition features. One such additional feature can bethe inclusion of a thermometer to track the user's temperature duringuse. Another additional feature can be the inclusion of a sleep sensoror sleep tracking program, wherein the therapy providing device can beutilized to track the user's sleep. For example, the sleep program mayutilize the GPS/accelerometer of the therapy providing device to trackmovement during sleep, wherein the sleep program could further utilizethe temperature data as well. Another aspect of the invention could beto utilize the therapy providing device to be further utilized todiagnose sleep apnea, wherein the therapy providing device could furtherinclude a microphone to enable audio recording of the user's breathingduring sleep. Additionally, the microphone recording of the breathingcan be combined with the accelerometer data or GPS/tilt data tocorrelate the breathing recordings to the specific user.

Referring now to FIGS. 21A and 21B there is shown a computing device 300in accordance with the present invention. The computing device 300includes a processor, memory, energy source (such as a battery), and adisplay. The computing device may be a custom manufactured device foruse with the therapy device 200 as described above, or alternatively,the computing device 300 may be a commercially available device such asa smartphone or tablet. Examples of such commercially available devicesare iOS enabled devices such as the iPhone®, iPad®, iPod®, Android basedphones and/or tablets, laptops or computers. As shown in FIG. 15B, thecomputing device may be configured to display a user's heart rate andblood pressure when connected to a therapy providing device having thosemeasurement capabilities or where other compatible devices are utilizedwith the therapy providing device. Alternatively, the computing devicemay display data received from one or more therapy providing devices,this data may include start/stop times of therapy provided by thetherapy providing device 200, battery status of one or more therapyproviding devices and the like.

In accordance with the present invention, the computing device 300 isconfigured to run a program 820. In accordance with the presentinvention, the program 820 is configured to communicate with the therapydevice 200. The communication between the program 820, computing device300 and the therapy device 200 may be conducted using BLUETOOTH, WIFI,ZIGBEE, NFC, RFID, ANT+, 3G/4G, cellular connection or other knownwireless communication protocols. Alternatively, the computing devicemay be coupled to at least one of the therapy devices through a cableconnection.

In an alternative embodiment, the program 820 is stored on memorylocated within the memory of the therapy providing device 200. Theprogram maybe initiated manually through the use of a physical buttonpressed by the user. Alternatively, the program 820 may be initiatedautomatically by a timer located within the therapy providing device200. The timer may further utilize data inputs from anaccelerometer/compass or tilt sensor to indicate when the user is in aprone position to initiate the program 820. Further still, the timer mayreceive input from an impedance sensor indicating whether the therapyproviding device 200 is in proper placement on the users body. Theprogram would then be initiated based on the inputs received. The devicemay be activated further by the light sensor either from the darknessagainst the skin. The device may be activated from the reduced lightfrom the users surroundings, for example when the user is sleeping.

In certain embodiments, the program 820 is pre-configured to delivertherapy using the therapy providing device through pre-programmedparameters. The HCP may adjust the therapy parameters within the program820, such that the therapy provided to the user may be customized to theuser. The customization of the therapy may be changes to the wavelength,amplitude, duration, start/stop times. The customization may be done bythe HCP while providing services to the patient, for example, the HCPmay apply the therapy providing device to the patient, initiate therapyand monitor the patient's response. Through this active monitoring, theHCP may change the parameters of the program to elicit a response in thepatient. For example, it is contemplated that certain patients may havedifferent bone densities; therefore the therapy provided by the devicemay need to be adjusted accordingly. It is further contemplated, thatonce programmed, the user cannot change the therapy parameters of theprogram, or alternatively, certain parameters or all parameters may beopen to change by the end user or remotely. Alternatively, the HCP,after determining the best therapy parameters, can choose from multipleprograms stored within memory of the therapy providing device. Furtherstill, the HCP may be provided with a dedicated programming device, ormay couple the device to a personal computer, smartphone, tablet orother internet enabled device, such that the HCP can utilize thededicated programmer or download over a secure internet connection,programs to be uploaded into the therapy providing device.

Referring now to FIG. 22, there is shown a flow diagram illustrating theprogram 820 in accordance with one embodiment of the present invention.As shown in FIG. 22, the program 820 may configured to be run on thecomputing device 800 to control the therapy applied to the user by thetherapy providing device 200. Alternatively, it is contemplated that theprogram 820 may reside within memory within the therapy providing device200 as described above.

At Box 830, the user activates the program on the computing device 800or therapy providing device 200.

At Box 840, the program checks the time on the computing device 800 orinternally from the clock circuit of the therapy providing device 200.

At Box 850, the program determines whether to turn the therapy providingdevice on based upon the time check in Box 840. If the time is before apre-programmed time or a user set time, then the program returns to Box840. If the time is after the pre-set time or user set time, then theprogram turns the therapy providing device on. In accordance with theinvention, if the time is received from the computing device, a user mayadjust the time of the computing device, for example if the computingdevice is moved from one time zone to another. Alternatively, thecomputing device may automatically update the time.

At Box 860, the therapy providing device 200 is provided with a signalgenerated by the program and transmitted from the computing device 800through a selected transmission method. In alternative embodiments, thetherapy providing device contains a processor and memory, wherein aprogram is retained within the memory of the therapy providing device.In this embodiment, the signal provided by the computing device 800, isa power on/off signal, wherein once powered on the program residingwithin the memory of the therapy providing device will begin to run.

At Box 870, the therapy device provides therapy to the patient. In theprocess of providing therapy, a signal is transmitted to the therapydevice 200 by the computing device 800 through as directed by theprogram 820, or as described above, the program residing in the memoryof the therapy providing device runs. In one embodiment, the therapy isapplied for a set period of time. In alternative embodiments, the timeduration of the therapy may be determined based upon data received fromother sensors disposed upon the user or about the user. In yet anotherembodiment, the user may manually deactivate the therapy providingdevice/program.

At Box 880, the therapy is stopped. The therapy may be stopped basedupon a time event, motion event, manually by the user, automatically bythe program.

During each of the steps described above and shown in the flow diagramof FIG. 22, the user may be presented with displays on the screen 810 ofthe computing device. The screen 810 may display the start and stoptimes of the therapy, these times may be set by the user or may be setfor the user by a health care provider. Alternatively, the times maybeautomatically generated in response to data received from other sensorsas will be described in detail below.

According to the invention, the program includes a non-transitorycomputer readable medium having computer executable program codeembodied thereon, the computer executable program code configured tosend appropriate signals to the circuit board(s) 500/550 to providetherapy in accordance with the methods of the present inventionutilizing the therapy providing device 200 of the present invention.

Methods of Use

In accordance with the present invention, methods of use of the presentinvention will be described below. The methods described shall beconsidered to be exemplary and should not be considered limiting in anymanner.

In accordance with one embodiment of the present invention, the therapydevice includes a driver assembly, wherein the driver assembly isembodied as a speaker as shown in FIG. 5. The speaker may be a hapticspeaker, a piezoelectric speaker, an electroactive polymeric transducer,or a magnetic coil speaker. The computing device 800 and program 810 areconfigured to provide a signal to the speaker to cause the speaker tovibrate at certain frequencies or to oscillate or translate through arange of frequencies.

In accordance with embodiments of the present invention, the frequenciescontemplated for use with the present invention range between 0 Hz to20,000 Hz, 0 Hz and 10,000 Hz, 0 Hz and 5,000 Hz, 0 Hz and 2,500 Hz, 0Hz and 1,750 Hz, 0 Hz and 875 Hz, 0 Hz and 435 Hz, 0 Hz and 200 Hz, 0 Hzand 150 Hz, 1 Hz and 150 Hz, 2 Hz and 150 Hz, 3 Hz and 150 Hz, 4 Hz and150 Hz, 5 Hz and 150 Hz, 6 Hz and 150 Hz, 7 Hz and 150 Hz, 8 Hz and 150Hz, 9 Hz and 150 Hz, 10 Hz and 150 Hz, 11 Hz and 150 Hz, 12 Hz and 150Hz, 13 Hz and 150 Hz, 14 Hz and 150 Hz, 15 Hz and 150 Hz, 16 Hz and 150Hz, 17 Hz and 150 Hz, 18 Hz and 150 Hz, 19 Hz and 150 Hz, 20 Hz and 150Hz, 21 Hz and 150 Hz, 22 Hz and 150 Hz, 23 Hz and 150 Hz, 24 Hz and 150Hz, 25 Hz and 150 Hz, 26 Hz and 150 Hz, 27 Hz and 150 Hz, 28 Hz and 150Hz, 28 Hz and 150 Hz, 29 Hz and 150 Hz, 30 Hz and 150 Hz, 31 Hz and 150Hz, 32 Hz and 150 Hz, 33 Hz and 150 Hz, 34 Hz and 150 Hz, 35 Hz and 150Hz, 36 Hz and 150 Hz, 37 Hz and 150 Hz, 38 Hz and 150 Hz, 39 Hz and 150Hz, 40 Hz and 150 Hz, 41 Hz and 150 Hz, 42 Hz and 150 Hz, 43 Hz and 150Hz, 44 Hz and 150 Hz, 45 Hz and 150 Hz, 46 Hz and 150 Hz, 47 Hz and 150Hz, 48 Hz and 150 Hz, 49 Hz and 150 Hz, 50 Hz and 150 Hz, 51 Hz and 150Hz, 52 Hz and 150 Hz, 53 Hz and 150 Hz, 54 Hz and 150 Hz, 55 Hz and 150Hz, 56 Hz and 150 Hz, 57 Hz and 150 Hz, 58 Hz and 150 Hz, 59 Hz and 150Hz, 60 Hz and 150 Hz, 61 Hz and 150 Hz, 62 Hz and 150 Hz, 63 Hz and 150Hz, 64 Hz and 150 Hz, 65 Hz and 150 Hz, 66 Hz and 150 Hz, 67 Hz and 150Hz, 68 Hz and 150 Hz, 69 Hz and 150 Hz, 70 Hz and 150 Hz, 71 Hz and 150Hz, 72 Hz and 150 Hz, 73 Hz and 150 Hz, 74 Hz and 150 Hz, 75 Hz and 150Hz, 76 Hz and 150 Hz, 77 Hz and 150 Hz, 78 Hz and 150 Hz, 79 Hz and 150Hz, 80 Hz and 150 Hz, 81 Hz and 150 Hz, 82 Hz and 150 Hz, 83 Hz and 150Hz, 84 Hz and 150 Hz, 85 Hz and 150 Hz, 86 Hz and 150 Hz, 87 Hz and 150Hz, 88 Hz and 150 Hz, 89 Hz and 150 Hz, 90 Hz and 150 Hz, 91 Hz and 150Hz, 92 Hz and 150 Hz, 93 Hz and 150 Hz, 94 Hz and 150 Hz, 95 Hz and 150Hz, 96 Hz and 150 Hz, 97 Hz and 150 Hz, 98 Hz and 150 Hz, 99 Hz and 150Hz, 100 Hz and 150 Hz, 101 Hz and 150 Hz, 102 Hz and 150 Hz, 103 Hz and150 Hz, 104 Hz and 150 Hz, 105 Hz and 150 Hz, 106 Hz and 150 Hz, 107 Hzand 150 Hz, 108 Hz and 150 Hz, 109 Hz and 150 Hz, 110 Hz and 150 Hz, 111Hz and 150 Hz, 112 Hz and 150 Hz, 113 Hz and 150 Hz, 114 Hz and 150 Hz,115 Hz and 150 Hz, 116 Hz and 150 Hz, 117 Hz and 150 Hz, 118 Hz and 150Hz, 119 Hz and 150 Hz, 120 Hz and 150 Hz, 121 Hz and 150 Hz, 122 Hz and150 Hz, 123 Hz and 150 Hz, 124 Hz and 150 Hz, 125 Hz and 150 Hz, 126 Hzand 150 Hz, 127 Hz and 150 Hz, 128 Hz and 150 Hz, 129 Hz and 150 Hz, 130Hz and 150 Hz, 131 Hz and 150 Hz, 132 Hz and 150 Hz, 133 Hz and 150 Hz,134 Hz and 150 Hz, 135 Hz and 150 Hz, 136 Hz and 150 Hz, 137 Hz and 150Hz, 138 Hz and 150 Hz, 139 Hz and 150 Hz, 140 Hz and 150 Hz, 141 Hz and150 Hz, 142 Hz and 150 Hz, 143 Hz and 150 Hz, 144 Hz and 150 Hz, 145 Hzand 150 Hz, 146 Hz and 150 Hz, 147 Hz and 150 Hz, 148 Hz and 150 Hz, 149Hz and 150 Hz, 150 Hz and 150 Hz, 60 Hz and 100 Hz, 61 Hz and 100 Hz, 62Hz and 100 Hz, 63 Hz and 100 Hz, 64 Hz and 100 Hz, 65 Hz and 100 Hz, 66Hz and 100 Hz, 67 Hz and 100 Hz, 68 Hz and 100 Hz 69 Hz and 100 Hz, 70Hz and 100 Hz, 60 Hz and 99 Hz, 61 Hz and 99 Hz, 62 Hz and 99 Hz, 63 Hzand 99 Hz, 64 Hz and 99 Hz, 65 Hz and 99 Hz, 66 Hz and 99 Hz 67 Hz and99 Hz, 68 Hz and 99 Hz, 69 Hz and 99 Hz and 70 Hz and 99 Hz, and 61 Hzand 98 Hz, 62 Hz and 98 Hz, 63 Hz and 98 Hz, 64 Hz and 98 Hz, 65 Hz and98 Hz, 66 Hz and 98 Hz, 67 Hz and 98 Hz, 68 Hz and 98 Hz, 69 Hz and 98Hz and 70 Hz and 98 Hz.

In a preferred embodiment the signal causes the driver assembly tovibrate at a frequency or sweep through a range of frequencies betweenabout 40 Hz and 150 Hz, more preferably between 50 Hz and 125 Hz, mostpreferably between about 60 Hz and 115 Hz. In accordance with thepresent invention, a therapeutic response has been achieved utilizing afrequency range between 65 Hz and 100 Hz.

It is further contemplated that these frequencies may be doubled andstill achieve the therapeutic lowering of blood pressure in accordancewith the present invention. It is further contemplated that thesefrequencies may be halved and still achieve the therapeutic lowering ofblood pressure in accordance with the present invention.

In additional embodiment of the present invention, the driver assemblymay vibrate or sweep or step between frequencies of between 60 Hz, 61Hz, 62 Hz, 63 Hz, 64 Hz, 65 Hz, 66 Hz, 67 Hz, 68 Hz, 69 Hz, 70 Hz, 71Hz, 72 Hz, 73 Hz, 74 Hz, 75 Hz, 76 Hz, 77 Hz, 78 Hz, 79 Hz, 80 Hz, 81Hz, 82 Hz, 83 Hz, 84 Hz, 85 Hz, 86 Hz, 87 Hz, 88 Hz, 89 Hz, 90 Hz, 91Hz, 92 Hz, 93 Hz, 94 Hz, 95 Hz, 96 Hz, 97 Hz, 98 Hz, 99 Hz and 100 Hz.

Referring now to FIGS. 23A and 23B, there is shown a further embodimentwherein the therapy is provided utilizing a combination of singlefrequencies and a sweeping frequency. For example, the driver assemblywould be driven to vibrate at a single frequency, F1, for a period oftime, then driven to sweep through a range of frequencies, F2, thendriven at a single frequency, F3, different than the first singlefrequency, F1, and then finally driven backwards through the sweep offrequencies above, F4. This cycle may be repeated for a set period oftime, turned off for a period of time and then repeated again, until anoverall time period of therapy is reached.

It is further contemplated that multiple signals utilizing separatefrequencies may be transmitted by the program to the speaker. Forexample, one signal may be transmitted at one frequency and a secondsignal at another frequency. The signals may be transmittedsimultaneously, independently or in an alternating fashion. If at leasttwo therapy providing devices 200 are utilized, then one therapyproviding device 200 may receive a first signal and the other receives asecond signal.

In one embodiment, at least two therapy providing devices 200 areutilized. In use a signal will be sent to one of the two therapyproviding devices 200, causing the speaker to emit a signal having achosen frequency or range of frequencies. The signal is transmitted to afirst therapy providing device 200 for a pre-determined period of time.After such time, the signal is terminated. Upon termination of the firstsignal, a second signal is generated and transmitted to the othertherapy providing device. This second signal causes the speaker to emita signal having a chosen frequency or range or frequencies. The chosenfrequency may be the same as that transmitted to the first therapyproviding device or it may be at a different frequency. The secondsignal will be transmitted to the second therapy providing device for apre-determined period of time. After such time, the signal isterminated. The program will continued to run, however, during this timeno signal will be transmitted to either therapy providing device 200,thereby creating a pause between activation of the therapy providingdevices 200. After the pre-determined time period of the pause haspassed, the program will then enter a loop and repeat the processdescribed above. This pattern of therapy will repeat for as long as theprogram has been instructed to do so.

In the embodiment where two therapy providing devices 200 are utilized,each of the devices deliver a waveform to the user's left and rightclavicle. The waveform is transmitted from the speaker in each of thetherapy providing devices to the user's clavicles. The waveform istransmitted through the clavicle on the left and right side, where bothwaves meet at the sternum to create a standing wave.

Further still, in accordance with the present invention, the amplitudeof the signal can be adjusted to adjust the sound pressure generated bythe driver assembly 220 of the therapy providing device 200. It iscontemplated that the amplitude may be doubled or increased even more todeliver the therapy in accordance with the present invention. Inaccordance with the invention, the therapy providing device 200 may beconfigured to provide a sound pressure between: 0 to 150 decibels, 0 to100 decibels, 0 to 99 decibels, 0 to 98 decibels, 0 to 97 decibels, 0 to96 decibels, 0 to 95 decibels, 0 to 94 decibels, 0 to 93 decibels, 0 to92 decibels, 0 to 91 decibels, 0 to 90 decibels, 0 to 89 decibels, 0 to88 decibels, 0 to 87 decibels, 0 to 86 decibels, 0 to 85 decibels, 0 to84 decibels, 0 to 83 decibels, 0 to 82 decibels, 0 to 81 decibels, 0 to80 decibels, 0 to 79 decibels, 0 to 78 decibels, 0 to 77 decibels, 0 to76 decibels, 0 to 75 decibels, 0 to 74 decibels, 0 to 73 decibels, 0 to72 decibels, 0 to 71 decibels, 0 to 70 decibels, 0 to 69 decibels, 0 to68 decibels, 0 to 67 decibels, 0 to 66 decibels, 0 to 65 decibels, 0 to64 decibels, 0 to 63 decibels, 0 to 62 decibels, 0 to 61 decibels, 0 to60 decibels, 0 to 59 decibels, 0 to 58 decibels, 0 to 57 decibels, 0 to56 decibels, 0 to 55 decibels, 0 to 54 decibels, 0 to 53 decibels, 0 to52 decibels, 0 to 51 decibels, 0 to 50 decibels, 0 to 49 decibels, 0 to48 decibels, 0 to 47 decibels, 0 to 46 decibels, 0 to 45 decibels, 0 to44 decibels, 0 to 43 decibels, 0 to 42 decibels, 0 to 41 decibels, 0 to40 decibels, 0 to 39 decibels, 0 to 38 decibels, 0 to 37 decibels, 0 to36 decibels, 0 to 35 decibels, 0 to 34 decibels, 0 to 33 decibels, 0 to32 decibels, 0 to 31 decibels, 0 to 30 decibels, 0 to 29 decibels, 0 to28 decibels, 0 to 27 decibels, 0 to 26 decibels, 0 to 25 decibels, 0 to24 decibels, 0 to 23 decibels, 0 to 22 decibels, 0 to 21 decibels, 0 to20 decibels, 0 to 19 decibels, 0 to 18 decibels, 0 to 17 decibels, 0 to16 decibels, 0 to 15 decibels, 0 to 14 decibels, 0 to 13 decibels, 0 to12 decibels, 0 to 11 decibels, 0 to 10 decibels, 0 to 9 decibels, 0 to 8decibels, 0 to 7 decibels, 0 to 6 decibels, 0 to 5 decibels, 0 to 4decibels, 0 to 3 decibels, 0 to 2 decibels, 0 to 1 decibels, 0 to 0.5decibels, 0 to 0.25 decibels, 10 to 100 decibels, 20 to 100 decibels, 30to 100 decibels, 40 to 100 decibels, 50 to 100 decibels, 60 to 100decibels, 70 to 100 decibels, 80 to 100 decibels, 90 to 100 decibels, 10to 75 decibels, 20 to 75 decibels, 30 to 75 decibels, 40 to 75 decibels,50 to 75 decibels, 60 to 75 decibels, 70 to 75 decibels, 10 to 65decibels, 20 to 65 decibels, 30 to 65 decibels, 40 to 65 decibels, 50 to65 decibels and 60 to 65 decibels, 20 to 30 decibels, 30 to 40 decibels,40 to 50 decibels, 50 to 60 decibels, 60 to 70 decibels, 70 to 75decibels, 80 to 90 decibels, 50 to 75 decibels and 50 to 65 decibels.

Further still, in accordance with the present invention, the standingwave may be of half-octave, double octave, or reflective incidence. Thusthe frequencies delivered at the collarbone may independently collideacross the breastbone or sternum and create a new frequency which is ofa different or same frequency as the generating waves.

In accordance with the present invention, the frequency selected fortherapy may be held constant while the sound pressure level can beincreased or decreased, alternatively, the sound pressure level may beheld constant and the frequency varied. The measurement of a soundpressure level is related to the displacement of a portion of thedelivery device 220. The portion of the delivery device 220 may bedisplaced between: 0 mm and 20 mm, 0 mm to 10 mm, 0 mm to 9 mm, 0 mm and8 mm, 0 mm to 7 mm, 0 mm to 6 mm, 0 mm to 5 mm, 0 mm and 4 mm, 0 mm and3 mm, 0 mm and 2 mm, 0 mm and 1 mm, 0 mm and 0.5 mm, 0 mm to 0.05 mm, 0mm to 0.005 mm, 0 mm to 0.0005 mm, 0.5 mm to 0.05 mm, 0.5 mm to 0.005mm, 0.05 mm to 0.005. If the delivery device 220 is selected to be thehaptic speaker 220′, then the portion of the haptic speaker 220′ beingdisplaced is the coil of the haptic speaker.

In accordance with the present invention, it is contemplated that eachtherapy providing device may be activated to provide therapy for a timeperiod between about 1 second and 24 hours. In other embodiments, thetherapy providing devices may be activated to provide therapy for a timeperiod of between about 1 second and 12 hours, 1 second and 11 hours, 1second and 10 hours, 1 second and 9 hours, 1 second and 8 hours, 1second and 7 hours, 1 second and 6 hours, 1 second and 5 hours, 1 secondand 4 hours, 1 second and 3 hours 1 second and 2 hours, and 1 second and1 hour, 1 second and 45 minutes, 1 second and 30 minutes, 1 second and20 minutes, 1 second and 15 minutes, 1 second and 10 minutes, 1 secondand 5 minutes and 1 second and 1 minute.

The overall therapy process may be conducted for a time period between 1second and 24 hours, 1 second and 23 hours, 1 second and 22 hours, 1second and 21 hours, 1 second and 20 hours, 1 second and 19 hours, 1second and 18 hours, 1 second and 17 hours, 1 second and 16 hours, 1second and 15 hours, 1 second and 15 hours, 1 second and 14 hours, 1second and 13 hours, 1 second and 12 hours, 1 second and 11 hours, 1second and 10 hours, 1 second and 9 hours, 1 second and 8 hours, 1second and 7 hours, 1 second and 6 hours, 1 second and 5 hours, 1 secondand 4 hours, 1 second and 3 hours, 1 second and 2 hours, 1 second and 1hour, 1 second and 45 minutes, 1 second and 30 minutes, 1 second and 15minutes, 1 second and 10 minutes, 1 second and 5 minutes, 1 second and 1minute.

In an alternative embodiment, instead of activating one therapyproviding device 200 at a time to conduct the therapy, both therapyproviding devices 200 may be activated at the same time.

In accordance with the present invention, the therapy device may befactory programmed to utilize a certain frequency or range offrequencies to provide therapy. Alternatively, the frequencies may beselected and programmed or chosen from memory by a health care providerbased upon a patient's response to a specific frequency or range offrequencies.

It is further contemplated that the computing device may be additionallyin communication with other sensors, such as a blood pressure monitor,heart rate monitor, pulse oximetry monitor, electrocardiogram (EKG/ECG),or glucose sensor.

In one embodiment the computing device 800 would receive data from theblood pressure monitor, or other sensor, such that the user's bloodpressure would be recorded before, during and after the application oftherapy in accordance with the present invention. This data, along withthe therapy data could be provided to the user and/or a health careprovider. Based upon the data, the frequency or range of frequenciesselected for therapy could be adjusted. The adjustments may be madeautomatically by the program, or by a health care provider or by theuser themselves.

In another embodiment, the processor of the therapy providing device 200may be in communication with other sensors, such as those describedabove, wherein the other sensors would be coupled in communication withthe therapy providing device. The processor within the therapy providingdevice 200 can receive data from various other sensors, such as a bloodpressure monitor. The data received from the blood pressure monitor maybe utilized by the program within the memory of the electronics moduleto further control the therapy providing device 200.

The signals generated by the program and transmitted to the therapyproviding device are preferably in the form of a sine wave. However,other wave forms may be utilized, such as a square waveform, sawtoothwaveform or triangle waveform.

It is further contemplated that additional sensors maybe utilized withthe methods and devices in accordance with the present invention. Forexample, a blood pressure monitor may be affixed to the patient asdescribed above. Other sensors, such as a sleep sensor, movement sensor,pulse oximetry sensor, temperature sensor, heart rate monitor, EKG,microphone, digital stethoscope, light sensor, sleep apnea device (CPAP)or camera may be used in combination with the therapy system 100 inaccordance with the present invention. The sensors listed above could beused separately or in combination to provide additional data to the useror a health care provider as to the health of the user as well as to theresponse of the user to the therapy provided by the therapy system 100.

It is further contemplated that any of the above sensors could beincorporated into the therapy providing device 200 in accordance withthe present invention. If incorporated into the therapy providing device200, the data from each of the additional sensors could be utilized bythe program to alter the therapy provided based upon data received fromthe various sensors. In an alternative embodiment, the data from each ofthe additional sensors could be stored on the resident memory containedwithin the therapy providing device 200. The therapy providing device200 could then be turned into a service center after a period of time,wherein the data contained within the memory can be retrieved andanalyzed. In yet another embodiment, the data stored within the memorycan be downloaded from the therapy providing device 200 each time thetherapy providing device is placed on the inductive charging pad. Thedata can then be transmitted to a collection center and analyzed.Additionally, the data could be uploaded to a server or otherinternet/network connected personal computer, such that the data couldbe viewed by the user, a health care provider or others.

In another embodiment, the device will store the number of uses anddurations of usage to allow the health care practitioner to determinecompliance of the patient. As in sleep apnea devices, reimbursement isonly allowed if the patient is 70 percent compliant, by tracking andrecording the usage of the therapy providing device of the presentinvention, this data could be utilized for reimbursement purposes.

In another embodiment, the therapy system 100 of the present inventioncould be associated with a home health system, such as Honeywell'sHOMMED system. In this embodiment, the therapy system 100 in accordancewith the present invention would be coupled to a monitoring system. Inthis embodiment, a health care provider could remotely monitor users aswell as their response to the therapy being provided. Further still, thetherapy system 100 may be configured to recognize an emergency, such asexcessively high blood pressure, excessively low blood pressure, highheart rate or low heart rate and generate an alert, such as an alarm ornotification to an emergency response unit to request help for the user.

In accordance with the present invention, the therapy device 200 asdescribed herein is disposed adjacent to or thereabout the clavicle justabove the brachial plexus of the user. It is contemplated that thetherapy providing device 200 may be placed at other locations on theuser such as the sternum, jaw, scapula, kneecap, wrist or skull. Whenactivated, the driver assembly 220 of the therapy device generates afrequency in the form of a sound wave; this sound wave is transmitted tothe clavicle and the skin adjacent the clavicle. The sound wavestransmitted to the clavicle are transmitted in the form of vibrations.The vibrations travel through the clavicle and into the skin, thearteries, vessels, nerves, sensory corpuscles, airways, bones near theclavicle, ligaments and tendons. As a result, the vibrations areeventually transmitted to the baroreceptors, the nociceptors, theproprioreceptors and other somatasory sensors. Here, the vibrationsinteract with the baroreceptors and other sensors in a manner to lowerblood pressure. In a preferred embodiment, the clavicle is chosenbecause it's easily accessible location as well as its ability totransmit sound or vibrations. The clavicle is easy to identify by ahealth care provider and a patient as it resides close to the surface ofthe skin regardless of body mass.

In accordance with the methods and devices of the present invention,activation of both the carotid and aortic baroreceptors as well as othersomatasory sensors can be achieved. It is believed that activation ofboth the carotid and aortic baroreceptors is beneficial in achievinglower blood pressure. It is believed that the methods provided accordingto the present invention mimic exercise, and therefore achieve alowering of blood pressure.

In accordance with the invention, the therapy may be provided at nighttime either right before the patient enters a sleep cycle or during asleep cycle of the patient. It may be beneficial to provide the therapyin accordance with the present invention at night time as it is believedthat one of the most important times to lower blood pressure is duringthe night. By providing therapy at night time in accordance with thepresent invention, the therapy can be utilized to address nighttimehypertension. Additionally, at nighttime, systemic drug levels are attheir lowest, therefore there is a need for additional blood pressurecontrol at this time.

In accordance with another embodiment of the present invention, it isbelieved that through the use of a single therapy providing deviceinstead of two therapy providing devices can be utilized to lower onlyDiastolic blood pressure, wherein the use of both therapy providingdevices can be utilized to lower both Systolic and Diastolic bloodpressure.

In accordance with the invention, the therapy may be provided prior to auser's sleep cycle and again in the morning either before they awake orshortly after they have woken up.

In accordance with the invention, the therapy providing device may beprogrammed with frequencies, wherein other frequencies may be utilizedto raise blood pressure at such times whereby raising the blood pressurewould be therapeutic and beneficial to a patient. It may be desirable toraise blood pressure after childbirth or to counteract episodes ofhypotension.

It is further contemplated that the device and methods according to thepresent invention may be utilized at any time. For example, it may bedesirable to utilize the device during the day time, where the devicecould be utilized in combination with a blood pressure monitor, oralternatively, incorporate a blood pressure monitor for closed loopcontrol. In this embodiment, the program would monitor the user's bloodpressure and apply therapy on an as needed basis. The user could selectto turn the system off if desired, for example if they are planning toengage in physical activity which will raise their blood pressure.

Test Results

In accordance with the present invention, and referring to FIGS. 24A and24B, the following blood pressure results were achieved through use ofthe device and methods described herein. FIGS. 24A and 24B illustrateambulatory blood pressure readings over a 24 hour period. Line 910 isthe European Society of Hypertension (ESH), the UK National Institutefor Health and Clinical Excellence (NICE) and American Society ofHypertension (ASH) recommended limits for Systolic blood pressure.Between the hours of 10 pm and 7 am a blood pressure of below 125 mmHgis considered to be at goal. During the daytime between the hours of 7am and 10 pm, a blood pressure below 140 mmHg is considered to be atgoal. Line 930 is the ESH, NICE and ASH recommended limits for Diastolicblood pressure, similar to the Systolic line 910, between the hours of10 pm and 7 am an at-goal Diastolic pressure is considered to be 80mmHg, and between the hours of 7 am to 10 pm a measurement of 90 mmHg isconsidered to be at goal.

As shown in FIG. 24A, lines 900 and 920 represent twenty-four (24) hourambulatory blood pressure measurements of an individual, wherein bloodpressure measurements were taken every fifteen (15) minutes. The userpresented in FIG. 24B would be considered to be hypertensive, that is tohave high blood pressure. This can be determined by looking specificallyat lines 900 and lines 920, wherein any time these lines are above therecommend guideline pressures, lines 910 and 930 the user would beconsidered to be hypertensive.

Referring now to FIG. 24A there is shown a graph of the same user afterhaving received therapy in accordance with the present invention. Inthis instance, the user received therapy at twice for two hours (2hours) each time as depicted items 940 and 950. Comparing the user'sactual blood pressure measurements, lines 900 and 920 of FIG. 24A, withthe user's treated actual blood pressure measurements, lines 901 and 902of FIG. 24A, it can be clearly seen that the user's blood pressure wassignificantly lowered through the application of therapy utilized thedevice and methods of the present invention.

To achieve the results depicted in FIG. 24A, two therapy providingdevices were utilized, one on the left clavicle and one on the rightclavicle. A frequency between 60 and 100 Hz was delivered by the speakerof each therapy providing device. The therapy providing devices wereutilized for a total of 4 hours of therapy, wherein the frequency of 65Hz was played for 8 seconds, followed by a sweep of frequencies from 65Hz to 98 Hz lasting 1 second, afterwards 98 Hz was played for 8 seconds,followed by a sweep of frequencies from 98 Hz to 65 Hz lasting for 1second. Therapy was provided, repeatedly for 120 minutes following thiscycle. After 120 minutes the therapy was suspended for a period of 4hours. After 4 hours of silence, an additional 120 minutes of therapywas delivered utilizing the cycle above.

Blood pressure measurements were taken before the application of thetherapy, whereby the user's Systolic blood pressure averaged 131 mmHg atnight time and 144 mmHg during the day. Diastolic blood pressure was 72mmHg at night time and 87 mmHg during the day. After using the therapyfor one evening (one 8 hour session as described above), Systolic bloodpressure averaged 116 mmHg at nighttime and 131 mmHg at daytime anddiastolic blood pressure averaged 66 mmHg at nighttime and 80 mmHg atdaytime.

Method of Action

In accordance with the present invention, as described in detail aboveand with reference to the included publications, it is understood thatbaroreceptors and nerves affect blood pressure through a measuredresponse generated by stretching or contraction of the arterial wall.

Nerve fibers, including baroreceptors, have the following input-outputcharacteristics; threshold pressure, saturation, post-excitatorydepression (PED), Asymmetric Rate Sensitivity and hysteresis.

As long as pressure within an artery remains below a certain level, nonerve firing occurs, this is referred to as the nerve thresholdpressure. Above the threshold pressure, the fiber responds by producingaction potentials, i.e., as signal. Individual fibers within humans andanimals possess a wide range of pressure threshold values.

As pressure increases within the artery, the firing rate of individualfibers increases. However, at certain pressure, further increases ininput yield no further increase in output frequency, thereby reachingthe saturation of the baroreceptor nerve.

If pressure input within the artery is stepped from a low pressure,which is higher than the threshold pressure, to a higher pressure, thenreturning to a lower pressure level, will result in a brief period ofshutoff, that is there will be no firing of the baroreceptor nerve, alsoreferred to as post-excitatory depression (PED). The baroreceptor nervewill return to its original firing rate after time.

Baroreceptor nerve frequency response to rising pressure is morepronounced than the response to falling pressure, otherwise known asasymmetric rate sensitivity.

Lastly, periodic inputs produce looping in pressure-frequency plots,another indication of the asymmetry between responses to rising andfalling pressures otherwise referred to as hysteresis.

In accordance with the present invention, utilization of the devices inaccordance with the methods described herein cause an activation of thenervous system which affect blood pressure. The nerve terminal endingsrespond to stretch or acoustic vibration, and produce afrequency-modulated train of action potentials which can override thenatural frequencies to elicit a response. Wherein the therapy providedby the invention, utilizes acoustic vibration of specific frequenciesapplied at specific time intervals to activate the body's nervous systemto elicit a blood pressure response. The therapy of the presentinvention is applied in a cyclic manner as it is believed that thebaroreceptors may become saturated if stimulated for too long of aperiod of time. If the therapy was applied continuously it is believedthat the baroreceptors would stop responding.

According to a method of the present invention, the therapy providingdevice is disposed adjacent to a user's clavicle. The clavicle being aDermal bone, is capable of transmitting vibrations. The clavicle liesabove the cerviocoaxillary which holds auxiliary arteries, veins,airways and the brachial plexus of nerves that supply the upper limb ofthe arm. Vibrating the clavicle is believed to create micro-pulsationswhich travel to the Aortic Baroreceptors and the Carotid BulbBaroreceptors. These micro-pulsations are believed to be perceived as anincrease in heart rate by the baroreceptors which then send a signal tothe brain. Thereby causing the body to lower blood pressure.

Selective stimulation of primary nerve endings can be obtained withcareful control of the amplitude, displacement and the mode ofapplication of the vibration or micro-pulsations.

What is claimed is:
 1. A method of treating hypertension in a subject,the method comprising: applying vibratory energy with at least onespeaker to at least one clavicle of the subject at a first vibrationfrequency; and applying vibratory energy with at least one speaker tothe at least one clavicle at a second vibration frequency different fromthe first vibration frequency, the applying steps being performed fortime periods sufficient to lower the subject's blood pressure.
 2. Themethod of claim 1, wherein the first and second vibration frequenciesare each between about 1 Hz and 20,000 Hz.
 3. The method of claim 1,wherein the first and second vibration frequencies are each between 35Hz and 150 Hz.
 4. The method of claim 1, wherein the first and secondvibratory energies are applied with first and second speakers,respectively.
 5. The method of claim 1, wherein the first and secondvibratory energies are applied with a first speaker to a right clavicleand to a left clavicle with a second speaker.
 6. The method of claim 1,further comprising applying vibratory energy with the at least onespeaker to the at least one clavicle at a plurality of vibrationfrequencies between the first vibration frequency and the secondvibration frequency.
 7. The method of claim 6, wherein the step ofapplying vibratory energy with the at least one speaker to the at leastone clavicle at a plurality of vibration frequencies comprises steppingbetween the plurality of vibration frequencies.
 8. The method of claim6, wherein the step of applying vibratory energy with the at least onespeaker to the at least one clavicle at a plurality of vibrationfrequencies comprises sweeping between the plurality of vibrationfrequencies.
 9. The method of claim 1, further comprising, prior to thefirst applying step, placing the at least one speaker over at least oneclavicle.
 10. The method of claim 9, wherein the placing step comprisesadhesively coupling the at least one speaker over at least one clavicle.11. The method of claim 9, further comprising adhesively attaching abandage to a skin surface over the at least one clavicle, the placingstep comprising coupling the at least one speaker to the bandage. 12.The method of claim 11, wherein the attaching step comprisesmagnetically coupling the at least one speaker to the bandage.
 13. Themethod of claim 1, wherein the applying steps comprises applying thefirst and second vibration frequencies in a cyclic manner sufficient toactivate a baroreflex response.
 14. A method of treating hypertension ina subject, the method comprising: adhesively disposing at least onespeaker over at least one clavicle of the subject; and using the atleast one speaker to apply vibratory energy for a time period sufficientto lower the subject's blood pressure.
 15. The method of claim 14,wherein the vibratory energy is applied at a vibration frequency ofbetween 1 Hz and 20,000 Hz.
 16. The method of claim 14, wherein thevibratory energy is applied at a vibration frequency of between 35 Hzand 150 Hz.
 17. The method of claim 14, wherein the vibration frequencyis a first vibration frequency, the method further comprising using theat least one speaker to apply vibratory energy to the at least oneclavicle at a second vibration frequency different from the firstvibration frequency.
 18. The method of claim 17, comprising using the atleast one speaker to apply the first and second vibration frequencies ina cyclic manner sufficient to activate a baroreflex response.
 19. Themethod of claim 14, wherein the step of using the at least one speakerto apply vibratory energy comprises stepping between a plurality ofvibration frequencies.
 20. The method of claim 14, wherein the step ofusing the at least one speaker to apply vibratory energy comprisessweeping between a plurality of vibration frequencies.